BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-35 XEO 5/100/130

    MDR report key: 18242797 · Received November 30, 2023

    Report

    Report Number
    1028232-2023-06061
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 8, 2023
    Report Date
    April 29, 2024
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640130452602
    PMA / PMN Number
    K222065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. THE TECHNICAL INVESTIGATION CONFIRMED THAT INFLATION OF THE BALLOON WAS IMPOSSIBLE AS THE ENTRANCE OF THE INFLATION LUMEN IN THE HUB WAS COVERED BY A TRANSPARENT POLYMER TUBE. THE ROOT CAUSE FOR THE REPORTED EVENT IS THEREFORE MOST LIKELY RELATED TO THE MANUFACTURING PROCESS. THE RELEVANT INTERNAL DEPARTMENTS WERE INFORMED ABOUT THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    A PASSEO-35 XEO BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION IN THE MILDLY TORTUOUS PROXIMAL TO MID SFA. IT WAS NOT POSSIBLE TO INFLATE THE BALLOON, EVEN THE PRESSURE WAS HELD AT 9 ATM. THE INFLATION DEVICE WAS CHECKED AND NO PROBLEM WAS FOUND. A SECOND ATTEMPT OF INFLATION WAS MADE BUT THE BALLOON STILL DID NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592670 PASSEO-35 XEO 5/100/130 CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 428889 02235665 07640130452602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown