Events

Safety Alert for Malecot Nephrostomy Catheters

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by Boston Scientific Philippines, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    2018-044
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/488558-fda-advisory-no-2018-044
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2018-044 voluntary recall of the malecot nephrostomy catheters with product registration mdr no. 02508 boston scientific philippines, inc., the importer/distributor of  malecot nephrostomy catheters  with the product registration number mdr-02508. has informed the food and drug administration of the voluntary recall of the said product, specifically described as follows: product description use material number malecot nephrostomy catheter malecot nephrostomy catheter re-entry ™ malecot nephrostomy percutaneous access set interventional radiology or urology m001224110 m0064101000 m0064101010 m0064101040 m0064101050 m0064201150 said items are being voluntarily recalled due to reports of some catheters breaking at the mid-shaft bond during use. the bond is located where the end of the malecot nephrostomy catheter is bonded to the catheter shaft. boston scientific philippines, inc. has received seventeen (17) complaints for this issue since december 1, 2013. if the catheter bond break while inside the patient, the most common adverse health consequence would be additional intervention for endoscopic retrieval of the detached fragment. the most severe consequence that is reasonably expected to occur due to this issue is an additional open or laparoscopic procedure to remove the detached fragment. lot and ref numbers that are critical in determining the identity of the product for traceability. in the report to the fda ,  boston scientific philippines, inc. disclosed that the affected lots were not distributed in the philippine market as per their distribution list record. at any rate, distributors, retailers and hospitals that have any lot of the stated medical device product are instructed to discontinue their further distribution, sale, and use. furthermore, other distributors of said product shall coordinate with the fda for the conduct of product recall. all consumers are likewise advised not to purchase or use the affected product lots. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested attachments: fda advisory no. 2018-044.Pdf.

Device

Malecot Nephrostomy Catheters

Manufacturer

Boston Scientific Philippines, Inc.
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    FDAP