Events

Recall of Bridge Balloon Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spectranetics Corporation.

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
    77934
  • Event Risk Class
    Class 1
  • Event Number
    Z-3106-2017
  • Event Initiated Date
    2017-08-07
  • Event Date Posted
    2017-08-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158269
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, intravascular occluding, temporary - Product Code MJN
  • Reason
    Possible inability to pass the guidewire through the bridge device, therefore, resulting in a potential delay of treatment.
  • Action
    The firm, Spectranetics, sent an "MEDICAL DEVICE RECALL" letter dated 08/07/2017 to customers via certified mail and an updated letter dated 8/17/2017 was sent on 8/23/2017. The letter described the product, problem and actions to be taken. The customers were Instructed to do the following: 1. For all Bridge inventory, we recommend physicians continue to follow product instructions to place a guide wire through the venous access site prior to the start of the procedure. Physicians may consider removing Bridge from packaging and placing the Bridge balloon over the wire prior to the start of the procedure to ensure a patent guidewire lumen if they believe the case is high risk. 2. All Bridge inventory will continue to have the potential for a guidewire lumen blockage until a solution is implemented. 3. Please bring your inventory into the case so that you have the back-up on hand, should you need it. 4. Always follow appropriate complication prevention and management protocols as it relates to patient preparation and surgical back up for lead extraction procedures. 5. Please complete the attached Acknowledgement and Receipt Form by EMAIL: Customer.Service@SPNC.com or FAX to: 1-877-447-2022. Your Spectranetics Sales Representative will be contacting you to facilitate the return and replacement of any remaining product in inventory once new inventory becomes available with an implemented fix; however, you may also reach Customer Service at 1-800-231-0978, Option 2. If you have additional questions please feel free to discuss with your local Spectranetics Sales Representative, or call the Vice President Quality Assurance directly at 719-447-2469. The Spectranetics Customer Service Department is also available to support you with any assistance you may need. Contact information:1-800-231-0978, Option 2 (Hours of Operation- Monday- Friday 7:00AM  5:00PM MST) or Email: Customer.service@spnc.com.

Device

Bridge Balloon Catheter
  • Model / Serial
    Model Number 590-001, Lots FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN47D12A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Poland, South Africa, Sweden, Switzerland, and United Kingdom.
  • Product Description
    Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. || Product Usage: || It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
  • Manufacturer
    Spectranetics Corporation

Manufacturer

Spectranetics Corporation
  • Manufacturer Address
    Spectranetics Corporation, 9965 Federal Drive, Colorado Springs CO 80921-3617
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA