BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 19182776 · Received April 25, 2024

    Report

    Report Number
    3015053858-2024-00036
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 25, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. THE CAUSE OF THE OCCLUSION CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. THE PHYSICIAN BELIEVES THE OCCLUSION MAY HAVE BEEN CAUSED BY THE ANGIO-SEAL CLOSURE DEVICE OR A CLOT. THERE WAS NO REPORTED MALFUNCTION OF THE IVL CATHETER. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. THEREFORE, REVIEW OF THE DEVICE MANUFACTURING AND TEST DOCUMENTATION COULD NOT BE COMPLETED. HOWEVER, SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED IN A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) CASE WITHOUT INCIDENT. FINAL ANGIOGRAM SHOWED AN OCCLUSION IN THE LEFT FEMORAL ARTERY, WHICH THE PHYSICIAN BELIEVES MAY HAVE BEEN CAUSED BY THE ANGIO-SEAL CLOSURE DEVICE OR A CLOT. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS ATTEMPTED, BUT A CUT DOWN WAS ULTIMATELY PERFORMED TO RE-ESTABLISH FLOW TO THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT WAS THEN DISCHARGED TO THE INTENSIVE CARE UNIT (ICU) IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614661 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H ANGIO-SEAL CLOSURE DEVICE - UNKNOWN MANUFACTURER