BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR-18 T3 6/200/135

    MDR report key: 20726554 · Received November 19, 2024

    Report

    Report Number
    1028232-2024-06044
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 14, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIP
    UDI-DI
    7640130447042
    PMA / PMN Number
    P160025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    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 THIS EVENT. THE TECHNICAL INVESTIGATION REVEALED MILD INDENTATIONS AT THE DISTAL END OF THE RETRACTABLE SHAFT AND NUMEROUS MILD KINKS IN THE DISTAL RETRACTABLE SHAFT PORTION. THE DEVICE SHAFT IS FURTHER STRONGLY KINKED ABOUT 102 MM PROXIMAL TO THE DISTAL END OF STABILIZER SHAFT. OUTSIDE OF THE DEFORMED ZONES, THE DIAMETER OF THE RETRACTABLE SHAFT COMPLIES WITH THE SPECIFICATION. AFTER FLUSHING, A 0.018 INCH REFERENCE GUIDEWIRE COULD BE FULLY INTRODUCED, HOWEVER, WITH STRONG RESISTANCE WHEN PASSING THE KINK IN THE DEVICE SHAFT. THE GUIDEWIRE AND THE INTRODUCER SHEATH USED IN THE INTERVENTION WERE NOT RETURNED. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. DURING FINAL INSPECTION, EVERY STENT SYSTEM UNDERGOES VISUAL INSPECTION, AND THE OUTER SHAFT DIAMETER IS MEASURED TO 100 PERCENT. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE COULD BE DETERMINED. THE KINK IN THE DEVICE SHAFT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, IT CANNOT BE RECONSTRUCTED IF THE KINK WAS INDUCED OR ALREADY PRESENT DURING LESION CROSSING OR LATER, E.G. DURING REPACKAGING FOR THE RETURN SHIPMENT.

    Description of Event or Problem · 0

    THE PULSAR-18 T3 STENT SYSTEM COULD NOT PASS THE LESION IN THE SFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431341 PULSAR-18 T3 6/200/135 STENT, SUPERFICIAL FEMORAL ARTERY NIP BIOTRONIK AG, BUELACH, SWITZERLAND 430506 11233738 7640130447042

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Hospitalization