BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 17492004 · Received August 9, 2023

    Report

    Report Number
    3015053858-2023-00049
    Event Type
    Death
    Date Received
    August 9, 2023
    Date of Event
    July 14, 2023
    Report Date
    February 20, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC
    Product Code
    QMG
    UDI-DI
    00195451000089
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED FOR INVESTIGATION AND INSPECTED. THE REPORTED FAILURE OF THE BALLOON BECOMING STUCK AND DETACHING FROM THE CATHETER WAS CONFIRMED. THE DEVICE WAS RECEIVED BROKEN AND SEPARATED INTO FOUR PIECES. ALL COMPONENTS WERE PRESENT AND ACCOUNTED FOR, INDICATING THAT NO FRAGMENTS WERE LEFT IN THE PATIENT. ALL EMITTERS SHOWED SIGNS OF WEAR INDICATING THAT THEY WERE FIRED AS EXPECTED. NO RUPTURES OR TEARS WERE NOTED ON THE BALLOON SURFACE. THE BALLOON WAS FOUND WRINKLED, WHICH INDICATES THAT IT LIKELY BECAME STUCK AND PREVENTED THE DEVICE FROM BEING REMOVED. THE EXACT CAUSE OF THE BALLOON BECOMING STUCK AND DETACHING FROM THE CATHETER COULD NOT BE DETERMINED. 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 OF SHOCKWAVE MEDICAL, INC. ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION THEREFORE, INSPECTION OF THE DEVICE COULD NOT BE PERFORMED. BASED ON THE REPORTED EVENT, WHEN ATTEMPTING TO REMOVE THE MEDTRONIC 6F TELESCOPE GUIDE EXTENSION, THE SHAFT OF THE SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SEPARATED. SNARING WAS ATTEMPTED TO RETRIEVE THE DEVICE BUT WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO THE OPERATING ROOM TO SURGICALLY REMOVE THE FRAGMENT, HOWEVER, THE PATIENT EXPIRED. 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 RELEASED FOR DISTRIBUTION. 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 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION LOCATED IN THE CORONARY ARTERIES. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE IVL CATHETER, IT GOT STUCK IN THE LESION. WHEN THE PHYSICIAN TRIED TO REMOVE THE MEDTRONIC 6F TELESCOPE GUIDE EXTENSION, THE SHAFT OF THE CATHETER SEPARATED. ALL ATTEMPTS TO SNARE THE BROKEN PIECE WERE UNSUCCESSFUL. THE PATIENT WAS SENT TO THE OPERATING ROOM (OR) TO SURGICALLY REMOVE THE FRAGMENT HOWEVER, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683700 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC C2IVL2512 A221128B 00195451000089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death MEDTRONIC 6F EBU 3.5 LAUNCHER - MEDTRONIC.| MEDTRONIC 6F TELESCOPE - MEDTRONIC.