BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 21829810 · Received April 11, 2025

    Report

    Report Number
    3015053838-2025-00061
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 17, 2025
    Report Date
    April 11, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    PMA / PMN Number
    K203365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED FOR INVESTIGATION AND INSPECTED. THE REPORTED FAILURES, "DETACHMENT OF DEVICE OR DEVICE COMPONENT" AND "MATERIAL SPLIT, CUT OR TORN" WERE CONFIRMED. THE RETURNED CATHETER WAS FOUND TO BE DAMAGED AND DETACHED AT THE INNER MEMBER AND BALLOON. A SECTION OF THE BALLOON, INNER MEMBER AND DISTAL TIP WERE NOT RETURNED AND COULD NOT BE INVESTIGATED FURTHER. THE DETACHMENT AT THE BALLOON AND INNER MEMBER WOULD CAUSE THE BALLOON TO LOSE PRESSURE AND INTRODUCED BLOOD INTO THE DEVICE DURING THE MEDICAL PROCEDURE. BASED ON THE INVESTIGATION OBSERVATIONS, THE BALLOON WAS LIKELY RUPTURED DUE TO PATIENT CALCIUM AND THE DEVICE GOT STUCK AT THE TREATMENT SITE DURING REMOVAL CAUSING IT TO DETACH. THE EXACT CAUSE OF THE DEVICE GETTING STUCK COULD NOT BE DETERMINED. HOWEVER, 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.

    Description of Event or Problem · 0

    A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT COMMON FEMORAL ARTERY (CFA). INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED, REVEALING THAT THE RIGHT ILIAC ARTERY MEASURED APPROXIMATELY 6.8MM. THE TRUE LUMEN WAS CONFIRMED, WITH NO EVIDENCE OF SUBINTIMAL POSITIONING. THE CALCIUM BURDEN IN THE VESSEL WAS SEVERE. NO PRE-DILATATION WAS REQUIRED, AND THE TREATMENT WAS PERFORMED IN A DE NOVO LESION. A TOTAL OF 120 PULSES WERE DELIVERED AT 2-4 ATM. DURING THE PROCEDURE, A BALLOON RUPTURE WAS IDENTIFIED AFTER DEFLATION OF THE IVL BALLOON, AS EVIDENCED BY BLOOD RETURNING FROM THE PORT. NO FURTHER IVL PULSES WERE ADMINISTERED. UPON REMOVAL OF THE IVL CATHETER, IT WAS NOTED THAT THE BALLOON WAS COMPROMISED, WITH THE COVERING MISSING FROM THE MOST DISTAL EMITTER TO THE DISTAL TIP OF THE CATHETER. THE LOCATION AND TIMING OF THE DETACHMENT ARE UNKNOWN, BUT ONCE THE BALLOON WAS REMOVED FROM THE BODY, PART OF IT WAS MISSING. NO EXCESSIVE FORCE WAS USED DURING DEVICE MANIPULATION, AS THE VESSEL WAS HEAVILY CALCIFIED. ADDITIONALLY, THE BALLOON WAS FULLY DEFLATED PRIOR TO EXTRACTION. TO ADDRESS THIS, IMMEDIATE WITHDRAWAL OF BLOOD FROM ALL PORTS OF THE SHEATH AND CATHETER WAS FACILITATED USING A 30CC SYRINGE. THE SHEATH WAS REMOVED AND THOROUGHLY FLUSHED. THE PHYSICIAN SUBSEQUENTLY STENTED THE RIGHT ILIAC ARTERY. PRIOR TO STENTING, NO DISSECTION OR EMBOLIZATION WAS OBSERVED, AND ALL VESSELS WERE PATENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. STENTS WERE SUCCESSFULLY DEPLOYED, AND THE PATIENT LEFT THE PROCEDURE WITH PALPABLE PULSES IN ALL EXTREMITIES. THE DETACHED BALLOON FRAGMENT WAS NOT RETRIEVED. A STENT WAS PLACED TO CONTAIN THE FRAGMENT AGAINST THE VESSEL WALL, AND THE PATIENT WAS KEPT IN THE HOSPITAL FOR OBSERVATION WITH NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2439765 SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PPN SHOCKWAVE MEDICAL, INC. M5PIVL7060 82297880

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other 0.14" SPARTACORE WIRE - ABBOTT.