BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 21236086 · Received January 24, 2025

    Report

    Report Number
    3015053858-2025-00010
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 26, 2024
    Report Date
    February 22, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000034
    PMA / PMN Number
    P200039/S00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SHOCKWAVE MEDICAL FOR INVESTIGATION AND THE REPORTED ISSUE WAS CONFIRMED. THE INVESTIGATION WAS LIMITED AS THE PROXIMAL PORTION OF THE CATHETER WAS NOT RETURNED. IT WAS REPORTED THAT THE IVL BALLOON WAS USED WITHIN A PRE-EXISTING STENT, WHICH IS OFF-LABEL PER THE DEVICE INSTRUCTIONS FOR USE. THE IFU ONLY INDICATES THE DEVICE FOR USE IN DE NOVO LESIONS. THE OFF-LABEL USE (INFLATION OF THE BALLOON WITHIN THE PRE-EXISTING STENT) IN COMBINATION WITH PATIENT CALCIUM LIKELY RESULTED IN DAMAGE TO THE BALLOON AND SUBSEQUENT BALLOON LOSS OF PRESSURE. USING THE DEVICE OFF-LABEL CAN INCREASE THE RISK OF FAILURE AND COMPLICATIONS. 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. FU1 FOR MFR# WAS INADVERTANTLY SUBMITTED AND ACKNOWLEDGED UNDER PATIENT IDENTIFIER CP-(B)(6) BUT SHOULD HAVE BEEN FU#1 FOR MFR# 3015053858-2025-00002. THIS REPORT IS BEING REFERENCED AS FU2 FOR SUCCESSFUL SUBMISSION AND RECEIPT, A CORRECTION REPORT WILL ALSO BE SUBMITTED FOR MFR# 3015053858-2025-00002.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SHOCKWAVE MEDICAL FOR INVESTIGATION. THE DEVICE ARRIVED BROKEN AND SEPARATED, INDICATING A SIGNIFICANT FAILURE IN ITS STRUCTURAL INTEGRITY. THE BALLOON'S WRINKLES AND THE BREAK IN THE OUTER SHAFT SUGGEST THAT THE DEVICE MIGHT HAVE GOTTEN STUCK DURING THE PROCEDURE. APPLYING FORCE TO REMOVE IT COULD HAVE CAUSED THE SEPARATION AND DAMAGE. ADDITIONALLY, THE BALLOON RUPTURE MIGHT HAVE BEEN ATTRIBUTED TO PATIENT CALCIUM. IT WAS REPORTED THAT THE DEVICE WAS USED AT 8 ATM, WHICH IS HIGHER THAN THE RECOMMENDED LITHOTRIPSY TREATMENT BALLOON PRESSURE. PER THE INSTRUCTIONS FOR USE (IFU), IT IS NOTED THAT: "4 ATM IS LITHOTRIPSY TREATMENT BALLOON PRESSURE, 6 ATM IS NOMINAL BALLOON PRESSURE AND POST-TREATMENT ANGIOPLASTY PRESSURE AND 10 ATM IS RBP (RATED BURST PRESSURE) OF THE BALLOON". USING THE DEVICE OFF-LABEL CAN INCREASE THE RISK OF FAILURE AND COMPLICATIONS. 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

    INVESTIGATION IS ONGOING AND RESULTS ARE NOT YET AVAILABLE.

    Description of Event or Problem · 0

    A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERY. IT WAS NOTED THAT 10 PULSES WERE DELIVERED AT AN UNKNOWN PRESSURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS A COMPLETE SEPARATION OF THE IVL CATHETER, WHICH REMAINED INSIDE THE PATIENT WHEN IT DETACHED. IT IS UNKNOWN WHETHER THE DEVICE WAS SUCCESSFULLY PREPPED OR IF THE BALLOON WAS FULLY DEFLATED BEFORE ATTEMPTING REMOVAL FROM THE SHEATH. ALTHOUGH THE PROCEDURE WAS COMPLETED, THE IVL PROCEDURE WAS NOT SUCCESSFUL. THE PATIENT REMAINED HOSPITALIZED BEFORE THE PATIENT WAS BROUGHT BACK TO THE LAB TWO DAYS LATER FOR A SECOND PROCEDURE TO RETRIEVE THE REMAINING CATHETER. APPROXIMATELY 28 CM OF THE DISTAL CATHETER WAS SNARED AND REMOVED FROM THE ASCENDING AORTA. THE LOCATION OF THE DETACHMENT RELATIVE TO THE BLUE STRAIN RELIEF IS UNKNOWN. ONCE THE CATHETER WAS REMOVED, NO FURTHER INTERVENTION WAS NECESSARY. IT IS ALSO UNCLEAR WHETHER BALLOON ANGIOPLASTY WAS PERFORMED. THE PHYSICIAN COULD NOT PROVIDE A REASONABLE EXPLANATION FOR THE BALLOON DETACHING FROM THE CATHETER. THE PATIENT HAS SINCE RECOVERED FROM THE PROCEDURE, WITH NO ADDITIONAL ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606624 SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL4012 09A240102A 00195451000034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown