BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 6/200/90

    MDR report key: 12540763 · Received September 28, 2021

    Report

    Report Number
    1028232-2021-05346
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 27, 2021
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640130429895
    PMA / PMN Number
    K151744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    28-SEP-2021 PMA NUMBER WAS INCORRECT ON THE ORIGINAL SUBMISSION. CORRECTED TO K151744. THE RETURNED INSTRUMENT WAS SUBJECTED TO A TECHNICAL ANALYSIS AND THE CORRESPONDING PRODUCT RELEASE 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 PROXIMAL PART OF THE BALLOON WHEN ATTEMPTING INFLATION. MICROSCOPIC ANALYSIS OF THE BALLOON SURFACE SHOWED A SMALL PINHOLE WITH DIAGONAL ORIENTATION ABOUT 31 MM DISTAL TO THE PROXIMAL X-RAY MARKER. AT THE ORIGIN OF THE PINHOLE SCRATCHES WERE OBSERVED WHICH HAVE LIKELY BEEN CAUSED BY A HARD, SHARP-EDGED OBJECT SUCH AS E.G. ANATOMICAL STRUCTURE. REVIEW OF THE PRODUCT RELEASE 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 AND A PRESSURE 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.

    Additional Manufacturer Narrative · 0

    28-SEP-2021: PMA NUMBER WAS INCORRECT ON THE ORIGINAL SUBMISSION. CORRECTED TO K151744.

    Description of Event or Problem · 1

    A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON WAS PLACED PROPERLY INSIDE THE LESION. AS THE BALLOON WAS INFLATED UP TO 6 BAR THE PRESSURE OF THE BALLOON WOULD SLOWLY TURN DOWN. TO KEEP THE BALLOON INFLATED AT 6 BAR IT WAS NECESSARY TO KEEP ON GIVING MORE PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440057 PASSEO-18 6/200/90 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 376282 03213423 07640130429895

    Patients

    Seq Age Sex Outcome Treatment
    1