BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-14 2/140/150

    MDR report key: 16451912 · Received February 28, 2023

    Report

    Report Number
    1028232-2023-01050
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    February 15, 2023
    Report Date
    February 27, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PRODUCT 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 AFFECTED BALLOON HAS BEEN INFLATED AND WAS DEFLATED IN THE AS RETURNED STATE. UPON INFLATION WITH 7 ATM (NP) THE BALLOON OPENED NORMALLY BUT THE PRESSURE DID NOT HOLD. A FINE JET OF WATER WAS SEEN TO EMERGE FROM THE DISTAL BALLOON PORTION. MICROSCOPIC INSPECTION REVEALED A PINHOLE ABOUT 21 MM PROXIMAL TO THE DISTAL X-RAY MARKER. IN CLOSE VICINITY TO THE PINHOLE A LONG DEEP SCRATCH WAS OBSERVED WHICH HAS 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 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 MATERIAL OR MANUFACTURING RELATED ROOT CAUSE WAS DETERMINED. THE ROOT CAUSE FOR THE COMPLAINT EVENT IS MOST LIKELY RELATED TO THE PATIENTS ANATOMY.

    Description of Event or Problem · 0

    A PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. WHEN INFLATING THE BALLOON UP TO 4.5 BAR, THE BALLOON CRACKED, ALTHOUGH NO CALCIFICATION WAS SEEN IN THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658178 PASSEO-14 2/140/150 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 380338 07222569 07640130433748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown