BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 2/170/150

    MDR report key: 5956368 · Received September 16, 2016

    Report

    Report Number
    1028232-2016-03715
    Event Type
    Malfunction
    Date Received
    September 16, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 14, 2016
    Manufacturer
    BIOTRONIK AG
    Product Code
    LIT
    PMA / PMN Number
    K151744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PASSEO-18 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 OF THE RETURNED BALLOON CATHETER REVEALED A LEAKAGE OF THE BALLOON. MICROSCOPIC ANALYSIS OF THE BALLOON SURFACE SHOWED THAT THE LEAKAGE SITE IS A SMALL TEAR LOCATED IN THE REGION OF THE DISTAL X-RAY MARKER. THE DISTAL X-RAY MARKER DID NOT SHOW ANY IRREGULARITIES. REVIEW OF THE PRODUCTION DOCUMENTATION VERIFIED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND FULFILLED ALL THE REQUIREMENTS OF 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 OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT NO MANUFACTURING OR MATERIAL RELATED ROOT CAUSE COULD BE DETERMINED. THE FINAL ROOT CAUSE FOR THE LEAKAGE IS MOST LIKELY RELATED TO EXTERNAL FACTORS DURING THE PROCEDURE.

    Description of Event or Problem · 1

    ON THE FIRST INFLATION THE PASSEO-18 BALLOON DID NOT EXPAND, THE PRESSURE IN THE INFLATION DEVICE WAS NOT ABLE TO EXCEED 2-3 ATMOSPHERES. THE BALLOON WAS REMOVED WITHOUT DIFFICULTIES. BLOOD WAS NOTED WITHIN THE BALLOON. THE PATIENT IS AN (B)(6) MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608272 PASSEO-18 2/170/150 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG 366137 01156233

    Patients

    Seq Age Sex Outcome Treatment
    1