BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-35 5/120/130

    MDR report key: 17755378 · Received September 15, 2023

    Report

    Report Number
    1028232-2023-04561
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    March 23, 2023
    Report Date
    September 14, 2023
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640130434608
    PMA / PMN Number
    K082933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE COMPLAINT INSTRUMENT NOR THE ANGIOGRAPHIC MATERIAL WAS RETURNED FOR ANALYSIS. THEREFORE, NO TECHNICAL INVESTIGATION ON THE SUBJECT COULD BE PERFORMED. THE PRODUCT RELEASE DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. 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 INFLATED BEFORE BALLOON FOLDING FOLLOWED BY A PRESSURE TEST AND A HELIUM LEAKAGE TEST TO CONFIRM THE AIR TIGHTNESS. ALL INSTRUMENTS OF THE RELEVANT LOT PASSED THESE TESTS. THE INSTRUMENT WAS DELIVERED IN A LEAK-PROOF AND PRESSURE-TIGHT CONDITION. BASED ON THE CONDUCTED INVESTIGATIONS, NO MANUFACTURING OR MATERIAL RELATED ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 0

    A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT. DURING ATTEMPT TO DILATE AN ARTERIOVENOUS FISTULA, THE BALLOON COULD NOT BE INFLATED, AND THE DEVICE WAS WITHDRAWN. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332895 PASSEO-35 5/120/130 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BIOTRONIK AG, BUELACH, SWITZERLAND 383278 07223449 07640130434608

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown