BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 5/120/130

    MDR report key: 16645720 · Received March 30, 2023

    Report

    Report Number
    1028232-2023-01601
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 6, 2023
    Report Date
    March 29, 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

    THE PASSEO-18 BALLOON CATHETER WAS CHOSEN TO CONDUCT THE PRE-DILATATION OF A MILDLY CALCIFIED LESION WITH 90 PERCENT STENOSIS DEGREE IN THE MODERATELY TORTUOUS SFA, BUT THE LESION COULD NOT BE PASSED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567278 PASSEO-18 5/120/130 PERIPHERAL DILATATION CATHETER LIT BIOTRONIK AG, BUELACH, SWITZERLAND 357511 05221181 07640119559223

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown