Events

Recall of Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boston Scientific Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01141-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01141-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Boston scientific has received reports from the field that the tip of the dilator has separated from the body of the dilator during procedure. if the tip broke off as the shaft was being advanced near the ureteopelvic junction (upj), then inadvertent blunt trauma to the renal parenchyma or renal hilar vessels could occur. this could produce anything from a small haematoma up to haemorrhage requiring medical therapy (transfusion), radiologic intervention (embolisation) or surgery (nephrectomy). however, in most cases the attempted removal of the tip would result in a second intervention. unless the tip fell off in the packaging or at placement over the guidewire the defect is unlikely to be detected prior to the procedure.
  • Action
    Boston Scientific are requesting users to inspect current stock and quarantine affected batches. Affected product can be returned to Boston Scientific for replacement or a credit note.

Device

Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage...
  • Model / Serial
    Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract)Catalogue Numbers: 250-227, 250-228 and 250-229 Material Numbers: M0062502270, M0062502280 and M0062502290Multiple Lot Numbers affectedARTG Number: 126446
  • Product Classification
    Gastroenterology-Urology Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 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
    DHTGA