BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 2/170/150

    MDR report key: 16936589 · Received May 15, 2023

    Report

    Report Number
    1028232-2023-02455
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 17, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640130414792
    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 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 TECHNICAL INVESTIGATION REVEALED TWO SMALL TEARS IN THE BALLOON SURFACE, ONE LOCATED AT THE PROXIMAL END AND ONE AT THE DISTAL END OF THE DISTAL RADIOPAQUE MARKER. SCRATCHES WERE OBSERVED IN CLOSE VICINITY OF BOTH TEARS WHICH HAVE LIKELY BEEN CAUSED BY A HARD, SHARP-EDGED OBJECT SUCH AS E.G. ANATOMICAL STRUCTURE. THE BALLOON IS SLIGHTLY UNFOLDED BUT HAS NOT BEEN INFLATED. 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. 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 COULD BE DETERMINED. THE ROOT CAUSE FOR THE COMPLAINT EVENT IS MOST LIKELY RELATED TO THE PATIENTS ANATOMY (I.E. SEVERE CALCIFICATION).

    Description of Event or Problem · 0

    THE PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS INFRAPOPLITEAL ARTERY. THE BALLOON COULD NOT BE INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678725 PASSEO-18 2/170/150 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 366137 03223255 07640130414792

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown