BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 14044577 · Received April 7, 2022

    Report

    Report Number
    3015053858-2022-00025
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 24, 2022
    Report Date
    March 24, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000069
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 3.0MM IVL BALLOON REFERENCED IN THIS REPORT WAS RETURNED TO SHOCKWAVE MEDICAL FOR INVESTIGATION. THE REPORTED BALLOON RUPTURE WAS CONFIRMED. THE 2.5MM IVL BALLOON WAS ALSO RETURNED AND THERE WAS NO DEVICE PROBLEM / MALFUNCTION OBSERVED. BASED ON THE REPORTED INFORMATION AND INVESTIGATION OBSERVATIONS, THE BALLOON RUPTURE COULD POSSIBLY BE ATTRIBUTED TO PATIENT CALCIUM. 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. A REVIEW OF THE LOT HISTORY RECORD (LHR) AND TEST DOCUMENTATION DID NOT SHOW ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL SHOCKWAVE MEDICAL, INC. CRITERIA PRIOR TO BEING RELEASE FOR DISTRIBUTION. CROSS-REFERENCE: MDR # 3015053858-2022-00026.

    Description of Event or Problem · 0

    A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON WAS USED IN A PATIENT WHO WAS TURNED DOWN FOR A CORONARY ARTERY BYPASS GRAFT (CABG), UNDERWENT A PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) AT THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND CIRCUMFLEX. ADDITIONALLY, THE PATIENT HAD ELEVATED ST AND WAS NOTED TO BE HAVING CHEST PAIN. ACCESS WAS OBTAINED VIA RIGHT FEMORAL APPROACH, AND THE TARGET LESION WAS PREPARED USING ROTATIONAL ATHERECTOMY. WHEN THE 3.0MM IVL BALLOON WAS AT THE MID LAD, 10 PULSES WERE DELIVERED, AND THEN THE BALLOON LOST PRESSURE . A SECOND IVL BALLOON (2.5MM) WAS INSERTED AND USED AS A TOOL TO KEEP THE VESSEL OPEN AND PRE-TREAT THE VESSEL PRIOR TO STENTING, BUT IT WAS NOT INFLATED, AND NO THERAPY WAS GIVEN . THE PATIENT'S CONDITION DECLINED UNEXPECTEDLY WITH EVIDENCE OF ASYSTOLE AND ABRUPT CLOSURE OF THE VESSEL. IMMEDIATELY THE PHYSICIAN BEGAN DIRECT STENTING OF THE LAD WITH A DRUG ELUTING STENT (DES) TO OPEN THE VESSEL. FOLLOWING STENTING, THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS AND THE PATIENT IS REPORTED TO BE STABLE WITH NO ADDITIONAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662624 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 A211021E 00195451000069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| O ATHERECTOMY (ROTOBLATOR) (UNKNOWN MANUFACTURER)| SYNERGY STENT (BOSTON SCIENTIFIC)