BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-35 4/100/130

    MDR report key: 12280369 · Received August 5, 2021

    Report

    Report Number
    1028232-2021-04422
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 12, 2021
    Report Date
    August 4, 2021
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640130434554
    PMA / PMN Number
    K082933
    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 PRODUCT RELEASE DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. IN ADDITION, THE ANGIOGRAPHIC MATERIAL PROVIDED WAS REVIEWED. THE TECHNICAL INVESTIGATION REVEALED THAT THE BALLOON HAS BURST LONGITUDINAL OVER A LENGTH OF ABOUT 49 MM. SCRATCHES WERE OBSERVED IN CLOSE VICINITY OF THE TEAR WHICH HAVE LIKELY BEEN CAUSED BY A HARD, SHARP EDGED OBJECT SUCH AS E.G. ANATOMICAL STRUCTURE. REVIEW OF THE ANGIOGRAPHIC MATERIAL DID NOT LEAD TO ANY FURTHER INFORMATION REGARDING THE NATURE OF THE COMPLAINT. THE ACTUAL COMPLAINT EVENT IS NOT VISIBLE. 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 PRESSURE TEST AND 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 FOR THE COMPLAINT EVENT IS MOST LIKELY RELATED TO THE PATIENTS ANATOMY.

    Description of Event or Problem · 1

    THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT. THE BALLOON RUPTURED BELOW RBP DURING DILATATION OF POPLITEAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178462 PASSEO-35 4/100/130 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BIOTRONIK AG, BUELACH, SWITZERLAND 383273 08200046 07640130434554

    Patients

    Seq Age Sex Outcome Treatment
    1