BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IV) CATHETER

    MDR report key: 16118408 · Received January 6, 2023

    Report

    Report Number
    3015053858-2023-00002
    Event Type
    Death
    Date Received
    January 6, 2023
    Report Date
    December 27, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    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. FOR INVESTIGATION THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. BASED ON THE REPORTED EVENT, THERE WAS NO MALFUNCTION OF THE SHOCKWAVE DEVICE. FOLLOWING A SUCCESSFUL SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IV) PROCEDURE, THE PHYSICIAN USED AN EMERGE PTCA DILATATION CATHETER WITH A SUPPORT OF A GUIDELINER WHICH CAUSED SPIRAL DISSECTION IN THE LAD. THIS EVENT CAUSED THE PATIENT TO BE TREATED USING AN IMPELLA SUPPORT, TEMPORARY PACEMAKER, AND WAS PROVIDED CARDIOPULMONARY RESUSCITATION (CPR). WHILE THE PATIENT WAS IN THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU), HE CODED AND EXPIRED. THE SITE REPORTED THAT SHOCKWAVE WAS UNLIKELY TO HAVE CAUSED THE PATIENT'S DEMISE. 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 PATIENT WHO HAD POSITIVE STRESS TEST (POSITIVE FOR CARDIAC ISCHEMIA) UNDERWENT A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TO TREAT A LESION IN THE DIAGONAL BRANCH OF THE CORONARY ARTERY. THE DIAGONAL BRANCH WAS THE ORIGINAL SITE TO BE TREATED. A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IV) CATHETER WAS USED, AND IT WAS REPORTED THAT TWO TREATMENTS WERE GIVEN IN THE DIAGONAL. POST IVL, THE MD USED AN EMERGE PTCA DILATATION CATHETER WITH A SUPPORT OF A GUIDELINER WHICH CAUSED SPIRAL DISSECTION IN THE LAD. THE MD TREATED THE DISSECTION IN THE LAD WITH SEVERAL STENTS HOWEVER, THE MD COULD NOT GET FLOW IN THE LAD. AT THIS POINT, THE PATIENT REQUIRED AN IMPELLA SUPPORT, TEMPORARY PACEMAKER, AND WAS PROVIDED CARDIOPULMONARY RESUSCITATION (CPR). AFTERWARDS, THE PATIENT WAS TRANSFERRED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) WHERE HE LATER CODED AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535932 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IV) CATHETER INTRAVASCULAR LITHOTRIPSY (IV) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL2512 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death EMERGE PTCA DILATATION CATHETER (BOSTON SCI)| GUIDELINER (UNKNOWN BRAND AND MANUFACTURER)| IMPELLA® HEART PUMP (JOHNSON AND JOHNSON)| PACEMAKER (UNKNOWN BRAND AND MANUFACTURER)| STENTS (UNKNOWN BRANDS AND MANUFACTURERS)