BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 4/120/130

    MDR report key: 19208083 · Received April 29, 2024

    Report

    Report Number
    1028232-2024-02389
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 16, 2024
    Report Date
    November 1, 2024
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640119559216
    PMA / PMN Number
    K072765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 TECHNICAL INVESTIGATION REVEALED THAT THE BALLOON HAS BURST LONGITUDINALLY OVER A LENGTH OF ABOUT 82 MM. MICROSCOPIC INSPECTION OF THE BALLOON SURFACE REVEALED SCRATCHES IN CLOSE VICINITY OF THE TEAR 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 DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. IN ADDITION TO VISUAL INSPECTIONS EACH DEVICE IS TESTED FOR AIR TIGHTNESS BY MEANS OF A PRESSURE TEST AND A HELIUM LEAK TEST. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE COULD BE DETERMINED. THE ROOT CAUSE FOR THE REPORTED EVENT IS MOST LIKELY RELATED TO THE PATIENTS ANATOMY.

    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 TECHNICAL INVESTIGATION REVEALED THAT THE BALLOON HAS BURST LONGITUDINALLY OVER A LENGTH OF ABOUT 82 MM. MICROSCOPIC INSPECTION OF THE BALLOON SURFACE REVEALED SCRATCHES IN CLOSE VICINITY OF THE TEAR 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 DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. IN ADDITION TO VISUAL INSPECTIONS EACH DEVICE IS TESTED FOR AIR TIGHTNESS BY MEANS OF A PRESSURE TEST AND A HELIUM LEAK TEST. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE COULD BE 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 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE FEMORAL-POPLITEAL AREA. THE COMPLAINT PASSEO-18 WAS POSITIONED ACROSS THE POPLITEAL ARTERY AND INFLATED AT NP 6 ATM FOR 2 MINUTES. THE BALLOON WAS DEFLATED AND PULLED BACK TO FURTHER INFLATE AT THE DISTAL SEGMENT OF SFA. AT THAT TIME, IT WAS NOTICED THAT THE BALLOON COULD NOT BE INFLATED WITH THE INFLATION DEVICE ANYMORE. THE BALLOON WAS THEN REMOVED FROM THE PATIENT AND A RUPTURED WAS NOTICED. THE PASSEO-18 BALLOON WAS THEN REPLACED WITH AN ARMADA-18 BALLOON TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277487 PASSEO-18 4/120/130 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 357510 10221748 07640119559216

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown