Bridge Balloon Catheter 의 리콜

Recall

77934

Class 1

Z-3106-2017

2017-08-07

2017-08-26

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158269

Possible inability to pass the guidewire through the bridge device, therefore, resulting in a potential delay of treatment.

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.