BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 16751755 · Received April 17, 2023

    Report

    Report Number
    3015053858-2023-00017
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    April 3, 2023
    Report Date
    April 3, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000102
    PMA / PMN Number
    P200039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 REPORTED SEPARATION WAS CONFIRMED. BASED ON THE INVESTIGATION PERFORMED, THE BALLOON MAY HAVE BEEN LIKELY GOT STUCK WITHIN THE SHEATH AND POSSIBLY EXCESS FORCE WAS USED TO TRY TO REMOVE IT. THIS RESULTED IN THE SEPARATION OF THE DISTAL SHAFT AND INNER LUMEN. THE CAUSE OF THE BALLOON BEING STUCK IN THE SHEATH COULD NOT BE DEFINITIVELY DETERMINED. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION FOR THE 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. 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

    IIT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES TO TREAT A CONCENTRIC DE NOVO LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. PRIOR TO THE START OF PROCEDURE, THE LESION WAS PRE-DILATED USING A NON-COMPLIANT (NC) BALLOON. THEN A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS ADVANCED TOWARDS THE TARGET VESSEL AND SUCCESSFULLY DELIVERED 80 PULSES TO THE TARGET LESION. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE IVL FROM THE PATIENT'S ANATOMY, RESISTANCE WAS ENCOUNTERED. AS THE IVL WAS BEING WITHDRAWN, THE BALLOON WAS CAUGHT IN THE TELEFLEX GUIDELINER AND IT SUBSEQUENTLY BROKE. THE INITIAL BREAK OCCURRED AT THE DISTAL TIP OF THE GUIDELINER, BUT THE COMPLETE SEPARATION WAS REPORTED TO BE INSIDE BUT COULD NOT BE DEFINITIVELY DETERMINED AS THE STAFF WAS NOT USING LIVE IMAGING UPON PULLING OUT THE CATHETER. THE PHYSICIAN USED SPECTRE¿ GUIDEWIRE TO SUCCESSFULLY RETRIEVE THE FRAGMENT(S) FROM THE GUIDELINER WHILE IT WAS STILL INSIDE THE PATIENT. POST IVL PROCEDURE, THE LESION WAS EXPANDED WITH A SYNERGY DRUG-ELUTING STENT (DES). THERE WERE NO PATIENT CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828251 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3512 A220719C 00195451000102

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female SPECTRE¿ GUIDEWIRE - TELEFLEX - TELEFLEX.| TELEFLEX GUIDELINER - TELEFLEX.