BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-14 2/140/150

    MDR report key: 11957218 · Received June 8, 2021

    Report

    Report Number
    1028232-2021-03207
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640130433748
    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. IN THE AS-RETURNED CONDITION THE BALLOON OF THE COMPLAINT INSTRUMENT IS NOT WELL FOLDED ANYMORE AND HAS CLEARLY BEEN INFLATED. AN INFLATION DEVICE FILLED WITH WATER WAS ATTACHED TO THE LUER PORT OF THE INFLATION LUMEN AND PRESSURE WAS APPLIED. WATER WAS FOUND LEAKING FROM THE LUER PORT OF THE GUIDEWIRE LUMEN. INSIDE THE HUB A LESS THAN 1 MM CUT WAS DETECTED IN THE INNER SHAFT, INDICATING PENETRATION WITH 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 PRESSURE TEST AND A HELIUM LEAK TEST. ALL TESTED INSTRUMENTS PASSED THESE TESTS. WE CAN THEREFORE CONFIRM THAT THE INSTRUMENT WAS DELIVERED IN A LEAK-PROOF CONDITION. BASED ON THESE FINDINGS IT SEEMS LIKELY THAT THE ROOT CAUSE FOR THE COMPLAINT EVENT IS RELATED TO EXTERNAL FACTORS DURING THE PROCEDURE OR ITS PREPARATIONS.

    Description of Event or Problem · 1

    THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS LEFT SUBCLAVIAN ARTERY. AFTER LESION CROSSING IT WAS NOT POSSIBLE TO INFLATE THE PASSEO-14 BALLOON CATHETER. THE DEVICE WAS REMOVED AND ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852595 PASSEO-14 2/140/150 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 380338 04204614 07640130433748

    Patients

    Seq Age Sex Outcome Treatment
    1