BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 5/120/130

    MDR report key: 16451913 · Received February 28, 2023

    Report

    Report Number
    1028232-2023-01046
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    February 13, 2023
    Report Date
    February 27, 2023
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640119559223
    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

    NEITHER THE COMPLAINT INSTRUMENT NOR THE ANGIOGRAPHIC MATERIAL WAS RETURNED. THEREFORE, NO TECHNICAL INVESTIGATION ON THE SUBJECT COULD BE PERFORMED. THE PRODUCT RELEASE DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. REVIEW OF THE PRODUCT RELEASE 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, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 0

    A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS OSTIAL FEMORAL ARTERY. THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658179 PASSEO-18 5/120/130 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 357511 03227050 07640119559223

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown