BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 13089698 · Received December 27, 2021

    Report

    Report Number
    3015053858-2021-00033
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    December 10, 2021
    Report Date
    December 10, 2021
    Manufacturer
    SHOCKWAVE MEDICAL INC.
    Product Code
    QMG
    UDI-DI
    00195451000096
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS RETURNED BY THE REPORTING PARTY. BASED ON AN EVALUATION OF THE RETURNED DEVICE, THE REPORTED FAILURE "FLASHES OF BLUE LIGHT OBSERVED IN THE SHOCKWAVE HUB" WAS CONFIRMED EVIDENCED BY RED AND BLACK WIRE INSULATION DAMAGE AT THE PROXIMAL END OF THE HYPOTUBE. THE ROOT CAUSE FOR THE SYMPTOMS THE ASSISTING NURSE REPORTEDLY EXPERIENCED COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. THE COMPLAINT DEVICE WAS TESTED BY SHOCKWAVE PERSONNEL AND COULD NOT CONFIRM THAT THE DEVICE WAS PROVIDING AN ELECTRIC SHOCK. THE CAUSE FOR THE REPORTED SPARKING IN THE HUB IS ATTRIBUTED TO THE WIRE INSULATION POSSIBLY BEING ACCIDENTALLY SCRATCHED/NICKED DURING THE MANUFACTURING PROCESS, EXPOSING THE BARE WIRES, AND CREATING A SPARK GAP IN THE DUAL-PORT HUB. SPARKING IN THE HUB IS A KNOWN DEVICE MALFUNCTION; EVEN THOUGH THE BROKEN/DAMAGED WIRES COULD CAUSE CURRENT LEAKAGE AND VISUAL FLASHING/SPARKING, THE LEAKAGE IS CONTAINED WITHIN A PLASTIC HUB AND DOES NOT POSE ANY RISK OF ELECTRICAL SHOCK TO THE USER AND/OR PATIENT. NO INSTANCES OF PATIENT HARM HAVE BEEN REPORTED/CONFIRMED TO BE CAUSED DUE TO THIS MALFUNCTION. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION DID NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SWMI'S ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Description of Event or Problem · 0

    A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DURING THE INITIATION OF THE SHOCKWAVE IVL THERAPY PROCEDURE, FLASHES OF BLUE LIGHT WERE OBSERVED IN THE SHOCKWAVE HUB, IN THE DIRECTION OF THE INDEFLATOR, AND THE ASSISTING NURSE REPORTED RECEIVED ELECTRIC SHOCKS IN HER HAND/FINGERS, WHICH WAS PAINFUL AND CAUSED A NUMB/STRANGE FEELING IN HER FINGERS LASTING FOR 3 HOURS. THE ASSISTING NURSE HAD NO INJURY TO HER FINGERS AND DID NOT REQUIRE ANY TREATMENT AND THE CONDITION OF HER FINGERS WAS REPORTED TO HAVE RESOLVED WITHOUT FURTHER INCIDENT. A NEW IVL CATHETER WAS OPENED AND THE IVL PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985763 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL INC. C2IVL3012 A210401C 00195451000096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other