BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 5/120/130

    MDR report key: 14579581 · Received June 2, 2022

    Report

    Report Number
    1028232-2022-02849
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 14, 2022
    Report Date
    May 31, 2022
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640119559223
    PMA / PMN Number
    K072765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. THE TECHNICAL INVESTIGATION REVEALED THAT THE BALLOON HAS BEEN INFLATED AND WAS DEFLATED IN THE AS-RETURNED STATE. UPON INFLATION THE PRESSURE COULD NOT BE HELD. A FINE JET OF WATER WAS SEEN TO EMERGE FROM THE PROXIMAL BALLOON PORTION. MICROSCOPIC INSPECTION SHOWED A PINHOLE IN THE BALLOON 20.5 MM PROXIMAL TO THE DISTAL X-RAY MARKER. IN CLOSE VICINITY OF THE PINHOLE A LONG SCRATCH WAS OBSERVED WHICH HAVE LIKELY BEEN CAUSED BY A HARD, SHARP-EDGED OBJECT SUCH AS E.G. ANATOMICAL STRUCTURE. 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 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 MATERIAL OR MANUFACTURING RELATED ROOT CAUSE WAS DETERMINED. THE ROOT CAUSE FOR THE REPORTED EVENT IS MOST LIKELY RELATED TO THE PATIENTS ANATOMY.

    Description of Event or Problem · 0

    A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS SFA. DURING INFLATION UP TO 6 ATM, IT WAS NOTED THAT CONTRAST MEDIUM WAS LEAKING OUT OF THE BALLOON. THE BALLOON CATHETER WAS WITHDRAWN AND A PINHOLE WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978543 PASSEO-18 5/120/130 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 357511 06213240 07640119559223

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown