BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 2.5/170/130

    MDR report key: 11200893 · Received January 20, 2021

    Report

    Report Number
    1028232-2021-00333
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    June 18, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640119559230
    PMA / PMN Number
    K072765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE COMPLAINT INSTRUMENT NOR THE ANGIOGRAPHIC MATERIAL WAS RETURNED FOR ANALYSIS. THEREFORE, NO TECHNICAL INVESTIGATION ON THE SUBJECT COULD BE PERFORMED. THE PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE PRODUCT DETAILED ABOVE VERIFIED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND FULFILLED ALL THE REQUIREMENTS OF IN-PROCESS AND FINAL INSPECTION. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT. THE SEVERELY CALCIFIED LESION COULD NOT BE CROSSED WITH THE DEVICE. NOTE THIS DEVICE HAS TWO PMA/510K NUMBERS. THE ADDITIONAL ONE IS K151744 WHICH CONTAINS A LINE EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97178 PASSEO-18 2.5/170/130 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 357512 07190360 07640119559230

    Patients

    Seq Age Sex Outcome Treatment
    1