BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 2/170/150

    MDR report key: 11373610 · Received February 24, 2021

    Report

    Report Number
    1028232-2021-00940
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 27, 2021
    Report Date
    February 24, 2021
    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

    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 REVEALED A FINE JET OF WATER EMERGING FROM THE CENTER OF THE BALLOON WHEN ATTEMPTING INFLATION. MICROSCOPIC ANALYSIS OF THE BALLOON SURFACE SHOWED A SMALL PINHOLE ON THE DISTAL X-RAY MARKER. CLOSE BY TO THE PINHOLE SEVERAL LONGITUDINAL DEEP SCRATCHES WERE OBSERVED. IT THEREFORE 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).

    Description of Event or Problem · 1

    A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE DORSALIS PEDIS ARTERY. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE INTERVENTION WAS COMPLETED WITH ANOTHER BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270933 PASSEO-18 2/170/150 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 366137 02203895 07640130414792

    Patients

    Seq Age Sex Outcome Treatment
    1