BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-14 2.5/140/150

    MDR report key: 11467157 · Received March 11, 2021

    Report

    Report Number
    1028232-2021-01188
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 24, 2021
    Report Date
    March 11, 2021
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640130433755
    PMA / PMN Number
    K152240
    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 INSTRUMENT WAS RETURNED WITH THE BALLOON PROTECTOR COVERING THE BALLOON. THE BALLOON IS WELL FOLDED AND SHOWS NO SIGNS OF INFLATION. FUNCTIONAL TESTING WAS PERFORMED BY INFLATING THE BALLOON UP TO NP. THE BALLOON OPENED BUT WATER WAS OBSERVED LEAKING FROM THE LUER PORT OF THE GUIDEWIRE LUMEN. MICROSCOPIC INSPECTION REVEALED A SMALL CUT WITH A LENGTH OF ABOUT 1 MM IN THE INNER SHAFT INSIDE THE HUB. THE CUT APPEARS AS IF IT WAS INDUCED BY A SHARP-EDGED OBJECT. 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 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.

    Description of Event or Problem · 1

    THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE). THE DEVICE WAS DELIVERED TO THE LESION BUT THE BALLOON COULD NOT BE INFLATED. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO FINISH THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357756 PASSEO-14 2.5/140/150 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 380339 12194131 07640130433755

    Patients

    Seq Age Sex Outcome Treatment
    1