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U.S. Department of Health and Human Services

Class 1 Device Recall Bridge Balloon Catheter

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  Class 1 Device Recall Bridge Balloon Catheter see related information
Date Initiated by Firm August 07, 2017
Date Posted August 26, 2017
Recall Status1 Terminated 3 on April 14, 2020
Recall Number Z-3106-2017
Recall Event ID 77934
510(K)Number K153530  
Product Classification Catheter, intravascular occluding, temporary - Product Code MJN
Product 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.
Code Information Model Number 590-001, Lots FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN47D12A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A.    Additional lots: FMN17H03A, FMN17H04A, FMN17H05A, FMN17H10A, FMN17H12A, FMN17H15A, FMN17H17A, FMN17H29A, FMN17J28A, FMN17K02A. 
Recalling Firm/
Manufacturer		 Spectranetics Corporation
9965 Federal Drive
Colorado Springs CO 80921-3617
For Additional Information Contact Customer Service
800-231-0978
Manufacturer Reason
for Recall		 Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
FDA Determined
Cause 2		 Nonconforming Material/Component
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. An additional letter was sent via electronic notific
Quantity in Commerce 2,356 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MJN and Original Applicant = SPECTRANETICS, INC.
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