BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 17777153 · Received September 19, 2023

    Report

    Report Number
    3015053858-2023-00054
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 31, 2023
    Report Date
    August 31, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000089
    PMA / PMN Number
    P200039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUSLY SUBMITTED REPORT INCLUDED THE MANUFACTURER NARRATIVE FOR THE INCORRECT DEVICE. THIS FOLLOW-UP REPORT IS A CORRECTION FOR THE EVALUATION OF THE CORRECT DEVICE. THE SUBJECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, A PHYSICAL INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. 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 RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE SHOWED NO SIGNS OF WEAR, AN INDICATION THAT THE EMITTERS WERE NOT FIRED. AS STATED IN THE INITIAL REPORT, THE 2ND IVL CATHETER WAS UNABLE TO CROSS SO NO PULSE WAS DELIVERED. BASED ON THE COMPLAINT DESCRIPTION, THE PHYSICIAN DECIDED TO TREAT THE CALCIFICATION PROXIMAL TO THE LESION. THE PHYSICIAN PULLED THE GUIDE EXTENSION BACK BUT KEPT THE IVL CATHETER IN THE SAME POSITION. WHILE PULLING OUT THE GUIDE EXTENSION, IT BROKE OFF. THE IVL CATHETER WAS USED TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT'S ANATOMY. 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 PATIENT UNDERWENT A PROCEDURE TO TREAT A CALCIFIED DE NOVO LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. PRIOR TO THE PROCEDURE, THE LESION WAS PRE-DILATED MULTIPLES TIMES USING A 2.0MM AND 2.5MM NON-COMPLIANT (NC) BALLOONS AT 12 ATMS. AN OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS TAKEN POST DILATATION TO TAKE IMAGES OF THE TARGET VESSEL. THEN THE PHYSICIAN ATTEMPTED TO ADVANCE A SHOCKWAVE C2 CORONARY INTRAVASCULAR (ILV) CATHETER TOWARDS THE LESION USING A 7F GUIDEPLUS¿ GUIDE EXTENSION CATHETER). HOWEVER, THE IVL WAS UNABLE TO CROSS THE LESION. THE IVL WAS REMOVED FROM THE PATIENT AND THE GUIDEPLUS¿ (GUIDE EXTENSION CATHETER) CATHETER WAS REPLACED WITH A 6F EASYGUIDE (EXTENSION CATHETER). THE IVL WAS SUCCESSFULLY INSERTED HOWEVER, IT WAS OBSERVED THAT THE CATHETER SHAFT WAS DEFORMED AROUND THE EXIT PORT. THE DEFORMED IVL WAS REPLACED WITH ANOTHER IVL CATHETER, BUT THE BALLOON WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN DECIDED TO TREAT THE CALCIFICATION PROXIMAL TO THE LESION, SO HE PULLED THE GUIDE EXTENSION BACK AND KEPT THE IVL CATHETER IN THE SAME POSITION. WHILE PULLING OUT THE GUIDE EXTENSION, IT BROKE OFF. THE IVL CATHETER WAS USED TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT'S ANATOMY. THE PHYSICIAN DECIDED NOT TO USE THE IVL ANYMORE AND INSTEAD, USED A CORONARY BALLOON (CB) CATHETER AS AN ALTERNATIVE. IT WAS FOLLOWED BY STENT IMPLANTATION TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986620 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL2512 10A230531A 00195451000089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 6F EASYGUIDE EXTENSION CATHETER - BOSTON SCI.| 7F GUIDEPLUS¿ EXTENSION CATH - BOSTON SCI.| NON-COMPLIANT (NC) BALLOON CATHETERS - UNK MFR.| OPTICAL COHERENCE TOMOGRAPHY (OCT).| STENT - UNKNOWN BRAND/ MANUFACTURER.