BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IV) CATHETER

    MDR report key: 16376074 · Received February 14, 2023

    Report

    Report Number
    3015053858-2023-00005
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    January 27, 2023
    Report Date
    January 27, 2023
    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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH THE BALLOON AND TIP MISSING. DURING THE INVESTIGATION, THE REPORTED BALLOON DETACHMENT WAS CONFIRMED HOWEVER, THE CAUSE OF THE BALLOON RUPTURE COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE RETURNED COMPONENTS. BASED UPON THE INVESTIGATION OBSERVATIONS, THE BALLOON POSSIBLY HAD A RADIAL TEAR WHICH PREVENTED IT FROM FULLY DEFLATING AND DURING REMOVAL, IT SOMEHOW GOT STUCK EITHER AT THE SHEATH ENTRANCE OR IN THE VESSEL. EXCESS FORCE WAS LIKELY USED TO REMOVE THE DEVICE WHICH WAS THE ORIGIN OF THE BALLOON AND INNER MEMBER TO SEPARATE. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION DID NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL SWMI'S ACCEPTANCE CRITERIA PRIOR TO SHIPPING. 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 WAS REPORTED TO BE HAVING CHEST PAIN UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A CALCIFIED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. ACCESS TO THE LESION WAS OBTAINED VIA FEMORAL APPROACH. PRIOR TO THE PROCEDURE, THE PATIENT WAS PUT ON HEPARIN AND SEDATION MEDICATIONS. THEN A ROTATIONAL ATHERECTOMY WAS PERFORMED TO HELP BREAK DOWN THE CALCIUM FOLLOWED BY PRE-DILATATION USING A NON-COMPLIANT (NC) ANGIOPLASTY BALLOON. THEN A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON WAS ADVANCED TOWARDS THE LESION AND AFTER DELIVERING 40 PULSES ON THE 2ND INFLATION AT 4 ATMS, THE BALLOON WOULD NOT HOLD PRESSURE. THE PHYSICIAN DEFLATED THE BALLOON AND PULLED THE CATHETER BACK TO THE GUIDE CATHETER WHERE IT WAS MET WITH RESISTANCE. AFTER THE IVL WAS REMOVED, IT WAS FOUND THAT HALF OF THE BALLOON MATERIAL WAS MISSING BUT THE REST OF THE CATHETER WAS INTACT. ANGIOGRAM SHOWED THE LAD WAS WITHOUT FLOW AND WIRE ACCESS WAS LOST. THE PHYSICIAN ATTEMPTED TO REWIRE THE NATIVE LAD HOWEVER, IT WAS UNSUCCESSFUL. SINCE THE PATIENT ALREADY HAD A GRAFT TO THE DISTAL LAD DUE TO PREVIOUS MULTIPLE BYPASS SURGERIES, ONE OF THE BYPASSES IS FEEDING OFF INTO THE LAD SO NO SURGICAL INTERVENTION WAS PROVIDED AT THE TIME. AFTER A STAY IN THE CATH LAB HOLDING AREA, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND SUBSEQUENTLY DISCHARGED TO HOME WITH NO CLINICAL SEQUELAE. THE PHYSICIAN DID NOT PERFORM ANY INTERVENTION BUT MIGHT ATTEMPT TO IMPLANT STENT AND PIN THE BALLOON FRAGMENT AGAINST THE VESSEL WALL AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126611 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IV) CATHETER INTRAVASCULAR LITHOTRIPSY (IV) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 A220502D 00195451000096

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| O| L GUIDE CATHETER - UNKNOW MANUFACTURER| NON-COMPLIANT BALLOON CATHETER - UNKNOWN MANUFACTU| ROTATIONAL ATHERECTOMY DEVICE - UNKNOWN MANUFACTUR