Class 2 Device Recall Bridge Occlusion Balloon

• Date Initiated by Firm: March 31, 2020
• Create Date: June 01, 2020
• Recall Status: Terminated on October 31, 2022
• Recall Number: Z-2143-2020
• Recall Event ID: 85477
• 510(K)Number: K153530
• Product Classification: Catheter, intravascular occluding, temporary - Product Code MJN
• Product: Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
• Code Information: All lots
• Recalling Firm/ Manufacturer: Spectranetics Corporation; 9965 Federal Dr; Colorado Springs CO 80921-3822
• For Additional Information Contact: Philips Image Guided Therapy Corp. CS; 800-231-0978 Ext. 2
• Manufacturer Reason for Recall: There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too long it could lead to embolization.
• FDA Determined Cause: Labeling design
• Action: A Field Safety Notification dated 3/31/20 was to be sent to all consignees utilizing regional sales managers and territory managers responsible for each customer account, beginning on March 31, 2020 via email or delivery in person depending on each account's restrictions due to COVID-19. The purpose of the letter was to to provide customers with an update regarding the Bridge occlusion balloon. They recently were made aware of an unpublished physician study that suggests potential formation of thrombus on the Bridge occlusion balloon when staged in patients for an extended period of time. It describes the risks to health as follows: The preliminary study results suggest that intravascular balloon staging with prolonged dwell times (average of 176 118 minutes) may be associated with an increased risk of thrombus formation. This study had one reported pulmonary embolism identified 3 days post procedure, which has not been attributed to the device. The rate of occurrence of the risk of harm is deemed to be remote (0.0108%), as no additional complaints for thrombus formation have been reported over the lifetime of the device outside of this preliminary study. This rate is within the expected range for lead extraction per HRS guidelines. The safety of the Bridge occlusion balloon has been well-proven among thousands of lead extractions over the last several years and remains effective in occluding SVC tears, significantly reducing the probability of mortality when used properly. Due to the rapid rate of blood loss associated with SVC tears, the Bridge device may be staged prophylactically to limit the time to occlusion. Actions to be taken by the Healthcare Professional: Inform potential users of the product in your organization of this notification, and complete and return the attached customer response form. At this time, the recommendation from their Medical Advisory Board is; when utilizing Bridge prophylactically, consider deployment after lead prepara
• Distribution: US: Nationwide OUS: Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, The Netherlands, and the United Kingdom of Great Britain and Northern Ireland
• 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