BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 6074083 · Received November 2, 2016

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    Report

    Report Number
    2015691-2016-03244
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 12, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PER HOSPITAL POLICY, THE CATHETER WILL NOT BE RETURNED FOR EXAMINATION. HOWEVER, THE CUSTOMER PROVIDED PHOTOGRAPHS OF THE CATHETER FOR A VISUAL EXAMINATION. THE REPORTED EVENT "THAT THE DISTAL TIP OF THE CATHETER (APPROX. 5MM) WAS MISSING" WAS CONFIRMED. AFTER REVIEW OF THE 3 PHOTOS, IT WAS OBSERVED THAT PART OF THE BALLOON LATEX, SPRING TIP AND THE DISTAL BALLOON WINDINGS APPEAR TO HAVE BEEN PULLED OFF THE CATHETER TIP. ALL THE SECTIONS OF THE BALLOON TIP THAT WERE PULLED OFF THE CATHETER WERE NOT VISIBLE IN THE PHOTOS. THE DISTAL WINDINGS APPEAR TO STILL BE ATTACHED. THE CATHETER BODY TUBE IS ALSO BROKEN IN HALF PROXIMAL OF THE 70CM MARKER. AS STATED IN THE IFU, BALLOON RUPTURE AND CATHETER SEPARATION AS A RESULT OF EXCESSIVE PULL FORCE APPLIED TO REMOVE ADHERENT MATERIAL ARE THE MOST FREQUENT CAUSES OF REPORTED FAILURES. THE POSSIBILITY OF BALLOON RUPTURE MUST BE TAKEN INTO ACCOUNT WHEN CONSIDERING THE RISKS INVOLVED IN ANY EMBOLECTOMY PROCEDURE. TO MINIMIZE THE RISK OF VESSEL DAMAGE, BALLOON RUPTURE, OR TIP DETACHMENT, DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION VOLUME AND PULL FORCE FOR EACH SIZE CATHETER. PER THE IFU THE MAX PULL FORCE FOR THIS CATHETER IS 0.7 LBS. ON AN INFLATED BALLOON. THE INSTRUCTIONS FOR USE FOR THE PRODUCT CONTAINS THE FOLLOWING STATEMENT: ¿AS WITH ALL CATHETERIZATION PROCEDURES, COMPLICATIONS MAY OCCUR. THESE MAY INCLUDE LOCAL OR SYSTEMIC INFECTION, LOCAL HEMATOMAS, INTIMAL DISRUPTION, ARTERIAL DISSECTION, PERFORATION AND VESSEL RUPTURE, HEMORRHAGE, ARTERIAL THROMBOSIS, DISTAL EMBOLIZATION OF BLOOD CLOTS AND ATHEROSCLEROTIC PLAQUE, AIR EMBOLUS, ANEURYSM, ARTERIAL SPASM, ARTERIOVENOUS FISTULA FORMATION, AND BALLOON RUPTURE WITH FRAGMENTATION, TIP SEPARATION AND DISTAL EMBOLIZATION.¿ BALLOON RUPTURE AND CATHETER SEPARATION AS A RESULT OF EXCESSIVE PULL FORCE APPLIED TO REMOVE ADHERENT MATERIAL ARE THE MOST FREQUENT CAUSES OF REPORTED FAILURES. TO MINIMIZE THE RISK OF VESSEL DAMAGE, BALLOON RUPTURE, OR TIP DETACHMENT, THE MAXIMUM RECOMMENDED INFLATION VOLUME AND PULL FORCE FOR THE CATHETER SHOULD NOT BE EXCEEDED. THE ARTERIAL EMBOLECTOMY CATHETER IS NOT RECOMMENDED FOR THE REMOVAL OF FIBROUS, ADHERENT, OR CALCIFIED MATERIAL (E.G. CHRONIC CLOT, ATHEROSCLEROTIC PLAQUE). THIS CATHETER IS NOT DESIGNED TO WITHSTAND THE ADDITIONAL PULL FORCE NEEDED TO REMOVE THESE MATERIALS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE PATIENT WITH A RIGHT BRACHIAL ARTERY THROMBOSIS UNDERWENT BRACHIAL ARTERY BYPASS WITH SAPHENOIUS VEIN GRAFT. DURING THE PROCEDURE, THE CATHETER APPEARED TO HAVE BECOME LODGED BUT DESPITE MULTIPLE MANEUVERS TO FREE, IT WOULD NOT DISLODGE. ON THE FINAL ATTEMPT, THE TIP OF THE BALLOON SHEARED AND THE REMAINDER OF THE CATHETER WAS REMOVED. FLUOROSCOPY WAS UNSUCCESSFUL IN FINDING THE MISSING TIP. FLOW WAS RESTORED AND NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724701 FOGARTY ARTERIAL EMBOLECTOMY CATHETER CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES 12A0803F 60212230

    Patients

    Seq Age Sex Outcome Treatment
    1 58 Required Intervention