BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 19725652 · Received July 11, 2024

    Report

    Report Number
    3015053858-2024-00066
    Event Type
    Injury
    Date Received
    July 11, 2024
    Report Date
    July 11, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 RELATIONSHIP BETWEEN THE IVL CATHETER AND THE REPORTED PERICARDIAL EFFUSION COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. THIS IS A KNOWN INHERENT RISK WITH THE PROCEDURE AND THE USE OF THE DEVICE. 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 DISTRIBUTION.

    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). THE IVL BALLOON RUPTURED AFTER 6 TREATMENT CYCLES. ANOTHER IVL BALLOON WAS USED AND DELIVERED 12 TREATMENT CYCLES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH STENTING. THE NIGHT OF THE INDEX PROCEDURE AND THE FOLLOWING DAY, THE PATIENT EXPERIENCED PLEURITIC CHEST PAINS. AN ECHOCARDIOGRAM SHOWED A SMALL PERICARDIAL EFFUSION. THE EVENT WAS RESOLVED AFTER THE PATIENT WAS PUT ON IV MEDROLIN FOR 36 HOURS. THE PHYSICIAN REVIEWED THE FILMS AND FOUND NO EVIDENCE OF EXTRAVASATION OR A PERFORATION. THIS REPORT IS FOR THE SECOND CATHETER USED IN THE PROCEDURE (REFER TO MDR 3015053858-2024-00065 FOR THE FIRST CATHETER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315860 SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL3012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H