BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 2/170/150

    MDR report key: 10960079 · Received December 7, 2020

    Report

    Report Number
    1028232-2020-05329
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    October 29, 2020
    Report Date
    December 4, 2020
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640130414792
    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

    COMBINATION PRODUCT: YES THE RETURNED INSTRUMENT WAS SUBJECTED TO A 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 OF THE RETURNED DEVICE REVEALED TWO TEARS WITH LENGTHS AND WIDTHS OF UP TO 1 MM, WHICH PENETRATES THE BALLOON WALL AND REACHES OVER A LENGTH OF 2 MM BEGINNING DISTAL TO THE DISTAL XRAY MARKER. IT SEEMS LIKELY THAT THE DAMAGE OF THE BALLOON SURFACE 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. WE CAN THEREFORE CONFIRM THAT THE INSTRUMENT WAS DELIVERED IN A LEAK-PROOF CONDITION. BASED ON THE CONDUCTED INVESTIGATIONS, NO MANUFACTURING OR MATERIAL RELATED ROOT CAUSE COULD BE DETERMINED. THE ROOT CAUSE IS MOST LIKELY RELATED TO THE PATIENTS ANATOMY (I.E. SEVERELY CALCIFIED TARGET LESION).

    Additional Manufacturer Narrative · 1

    COMBINATION PRODUCT: YES.

    Description of Event or Problem · 1

    A PASSEO 18 BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION IN THE ARTERIAE TIBIALIS ANTERIOR. THE PASSEO 18 BALLOON WAS USED TO DILATE THE LESION. ALTHOUGH THE PRESSURE COULD NOT BE MAINTAINED, IT WAS TRIED SEVERAL TIMES, BUT THE BALLOON STILL COULD NOT BE FILLED DURING THE EXPANSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423026 PASSEO-18 2/170/150 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 366137 12190377 07640130414792

    Patients

    Seq Age Sex Outcome Treatment
    1