BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 3/120/130

    MDR report key: 19219900 · Received May 1, 2024

    Report

    Report Number
    1028232-2024-02402
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 17, 2024
    Report Date
    November 1, 2024
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640119559193
    PMA / PMN Number
    K072765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PRODUCT 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. THE AFFECTED BALLOON HAS BEEN INFLATED AND WAS RETURNED FULLY DEFLATED. DURING FUNCTIONAL TESTING A FINE JET OF WATER WAS SEEN TO EMERGE FROM THE DISTAL BALLOON PORTION. MICROSCOPIC INSPECTION SHOWED A PINHOLE ABOUT 25 MM PROXIMAL TO THE DISTAL RADIOPAQUE MARKER. IN CLOSE VICINITY TO THE PINHOLE SCRATCHES WERE OBSERVED WHICH HAVE LIKELY BEEN CAUSED BY A HARD, SHARP-EDGED OBJECT SUCH AS E.G. ANATOMICAL STRUCTURE. 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 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 (I.E. CALCIFIED LESION).

    Additional Manufacturer Narrative · 0

    CORRECTED THE INITIAL REPORTER INFORMATION. REFERENCE CAPA# NC-24-004. THE RETURNED PRODUCT 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. THE AFFECTED BALLOON HAS BEEN INFLATED AND WAS RETURNED FULLY DEFLATED. DURING FUNCTIONAL TESTING A FINE JET OF WATER WAS SEEN TO EMERGE FROM THE DISTAL BALLOON PORTION. MICROSCOPIC INSPECTION SHOWED A PINHOLE ABOUT 25 MM PROXIMAL TO THE DISTAL RADIOPAQUE MARKER. IN CLOSE VICINITY TO THE PINHOLE SCRATCHES WERE OBSERVED WHICH HAVE LIKELY BEEN CAUSED BY A HARD, SHARP-EDGED OBJECT SUCH AS E.G. ANATOMICAL STRUCTURE. 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 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 (I.E. CALCIFIED LESION).

    Description of Event or Problem · 0

    A PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (STENOSIS DEGREE: 50 PERCENT) IN THE MODERATELY TORTUOUS POSTERIOR TIBIAL ARTERY (PTA). THE PASSEO-18 WAS INFLATED AT THE PTA LESION AT 6 ATM. HOWEVER, AS THE BALLOON WAS INFLATING, IT WAS OBSERVED THAT BLOOD WAS FLOWING INTO THE INFLATION DEVICE. IT WAS SUSPECTED THAT THE BALLOON WAS RUPTURED BUT THE BALLOON WAS ABLE TO INFLATE AND MAINTAINED AT 6 ATM EVEN THOUGH BLOOD CONTINUE TO FLOW INTO THE INFLATION DEVICE. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT WITHOUT DIFFICULTIES. A NEW BALLOON WAS USED AND THE LESION SUCCESSFULLY DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172278 PASSEO-18 3/120/130 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 357508 01222665 07640119559193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown