BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 22188680 · Received June 11, 2025

    Report

    Report Number
    3015053858-2025-00071
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 16, 2025
    Report Date
    June 11, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000003
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 ROOT CAUSE OF THE DETACHMENT AND DIFFICULTY IN REMOVING COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THE PHYSICIAN NOTED THAT THE DETACHED PORTION OF THE DEVICE REMAINS IN THE PATIENT. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION FOR SUBJECT LOT DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL SHOCKWAVE MEDICAL, INC. ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Description of Event or Problem · 0

    A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND GOT STUCK. IT WAS REPORTED THAT THE SHAFT OF THE CATHETER WAS LODGED IN THE PATIENT'S AORTA, AND THE BALLOON REMAINED STUCK IN THE LAD. THE PATIENT HAD A PRIOR LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT, WHICH WAS SUCCESSFULLY REOPENED DURING THE PROCEDURE. IT WAS REPORTED THAT DUE TO THE BALLOON BEING TRAPPED IN THE LAD, THE CLINICAL TEAM PROCEEDED TO INTERVENE ON THE LIMA AND PLACED A STENT IN THE LEFT MAIN ARTERY TO ENSURE CONTINUED BLOOD FLOW AND VESSEL PATENCY. ADDITIONAL INFORMATION WAS PROVIDED ON MAY 23,2025 INDICATING THAT A 7F CATHETER WAS USED FOR DEVICE DELIVERY AND THAT THE DETACHMENT OCCURRED INTRAPROCEDURAL. IT WAS ALSO NOTED THAT THE BALLOON WAS FULLY DEFLATED PRIOR TO THE ATTEMPTED REMOVAL. AFTER THE DETACHMENT WAS OBSERVED, A SNARE WAS USED TO RETRIEVE THE LODGED SHAFT OF THE CATHETER, BUT EFFORTS WERE UNSUCCESSFUL. THE SMALL PIECE REMAINS IN THE PATIENT AND IS EXPECTED TO BECOME ENDOTHELIALIZED OVER TIME. THE PATIENT WAS DISCHARGED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87705 SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL2512 31A240928B 00195451000003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other STENT- MANUFACTURE UNKNOWN