BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 19833635 · Received July 25, 2024

    Report

    Report Number
    3015053858-2024-00078
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    June 18, 2024
    Report Date
    September 21, 2024
    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
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED FOR INVESTIGATION AND INSPECTED. THE REPORTED FAILURE OF BALLOON LOSS OF PRESSURE WAS CONFIRMED. THE CAUSE OF THE PERFORATION COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. BALLOON RUPTURES ARE A KNOWN FAILURE MODE WITH A LOW PROBABILITY OF OCCURRENCE. CONTRIBUTING FACTORS INCLUDE PATIENT CALCIUM, DAMAGE CAUSED WHEN THE BALLOON WALL COMES INTO CLOSE CONTACT WITH THE DEVICE EMITTERS, LIKELY CAUSES INCLUDE (A) AN IRREGULAR CALCIUM LESION CAPABLE OF COMPRESSING THE BALLOON WALL INTO CLOSE PROXIMITY WITH THE EMITTER(S) AND/OR (B) AN INCOMPLETELY INFLATED BALLOON. THE SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER GENERATES ACOUSTIC PRESSURE PULSES WITHIN THE TARGET TREATMENT SITE, DISRUPTING CALCIUM WITHIN THE LESION ALLOWING SUBSEQUENT DILATATION OF A CORONARY ARTERY STENOSIS USING LOW BALLOON PRESSURE NOT TO EXCEED 4 ATM DURING IVL TREATMENT, AND 6 ATM FOR POST DILATATION. THE PRESSURE USED FOR THE IVL BALLOON CATHETER IS MUCH LOWER THAN OTHER BALLOON CATHETERS USED IN PERCUTANEOUS CORONARY INTERVENTION (PCI), THUS THE RISK ASSOCIATED WITH LOSS OF BALLOON PRESSURE DURING IVL CATHETER USE IS NEGLIGIBLE. THE ASSOCIATED PATIENT RISK FOR THIS FAILURE MODE IS LOW AND ADEQUATELY CAPTURED IN SWMI'S RISK DOCUMENTATION. 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 HAS NOT YET BEEN RECEIVED AT SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION HAS NOT BEEN PERFORMED. EVALUATION OF THE SUBJECT DEVICE IS ANTICIPATED BUT HAS NOT YET BEGUN. AFTER THE DEVICE IS RECEIVED AND INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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

    BASED ON NEW INFORMATION RECEIVED 17-SEP-2024, IT WAS CONFIRMED THAT THE PATIENT'S VESSEL WAS NOT RUPTURED AND THAT THERE WAS NO ADVERSE EFFECTS. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE.

    Description of Event or Problem · 0

    A SHOCKWAVE C2 CORONARY INTRAVASCULAR (IVL) LITHOTRIPSY CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERIES. THE IVL BALLOON RUPTURED DURING THE SECOND CYCLE, RESULTING IN LOSS OF PRESSURE. BLOOD WAS NOTED AT THE END OF THE CATHETER WHERE IT WAS CONNECTED TO THE PRESSURE PUMP. A NEW IVL CATHETER WAS USED AND DURING CATHETER DELIVERY, IT WAS OBSERVED THAT THE PATIENT'S BLOOD VESSELS WERE RUPTURED BY THE ABRASION OF SHARP CALCIFIED NODULES. THE PROCEDURE WAS COMPLETED AFTER A STENT WAS PLACED. THE PATIENT'S CURRENT STATUS IS UNKNOWN. THIS REPORT IS FOR THE FIRST CATHETER USED IN THE PROCEDURE. PLEASE REFER TO MDR# 3015053858-2024-00079 FOR THE SECOND CATHETER.

    Description of Event or Problem · 0

    BASED ON NEW INFORMATION RECEIVED 17-SEP-2024, IT WAS CONFIRMED THAT THE PATIENT'S VESSEL WAS NOT RUPTURED AND THAT THERE WAS NO ADVERSE EFFECTS. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243798 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 03A230509A 00195451000096

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other PTCA GUIDEWIRE - UNKNOWN MANUFACTURER.| RADIAL SHEATH - UNKNOWN MANUFACTURER.