BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 6/120/130

    MDR report key: 10030976 · Received May 6, 2020

    Report

    Report Number
    1028232-2020-01944
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Date of Event
    March 11, 2020
    Report Date
    May 5, 2020
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640130414693
    PMA / PMN Number
    K072765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED INSTRUMENT WAS SUBJECTED TO A DETAILED TECHNICAL ANALYSIS AND THE CORRESPONDING PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. THE TECHNICAL INVESTIGATION REVEALED THAT THE BALLOON HAS BURST LONGITUDINAL OVER A LENGTH OF ABOUT 25 MM. MICROSCOPIC INSPECTION OF THE BALLOON SHOWED SEVERAL DEEP SCRATCHES IN CLOSE VICINITY OF THE TEAR. IT SEEMS LIKELY THAT THE TEAR IN THE BALLOON WAS CAUSED BY A HARD, SHARP EDGED OBJECT PRESSING AGAINST THE BALLOON FROM THE OUTSIDE. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. IN ADDITION TO VISUAL INSPECTIONS EACH INSTRUMENT IS TESTED FOR AIR TIGHTNESS BY MEANS OF A HELIUM LEAK TEST. THE INSTRUMENT WAS DELIVERED IN A LEAK-PROOF CONDITION. BASED ON THE CONDUCTED INVESTIGATIONS NO MANUFACTURING RELATED ROOT CAUSE COULD BE DETERMINED. THE ROOT CAUSE IS MOST LIKELY RELATED TO THE PATIENTS ANATOMY.

    Description of Event or Problem · 1

    A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE SFA. AN INFLATION DEVICE WAS USED. AT 10 BAR PRESSURE THE BALLOON RUPTURED AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492477 PASSEO-18 6/120/130 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 366127 10196997 07640130414693

    Patients

    Seq Age Sex Outcome Treatment
    1