BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 12869298 · Received November 24, 2021

    Report

    Report Number
    3015053858-2021-00026
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 26, 2021
    Report Date
    October 26, 2021
    Manufacturer
    SHOCKWAVE MEDICAL INC.
    Product Code
    QMG
    UDI-DI
    00195451000119
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION PER THE REPORTED INFORMATION, THE DEVICE WAS USED OFF LABEL AS IT WAS PULSED WITHIN A STENT, AND THE C2 DEVICE IS ONLY INDICATED FOR USE IN DE NOVO CORONARY ARTERIES PRIOR TO STENTING. ADDITIONALLY, AFTER THE 80 PULSES WERE DELIVERED IT WAS NOTED THAT THE DEVICE WAS "TAKEN UP TO 10ATM TO DILATE THE AREA OF INTEREST." HOWEVER, THE IFU STATES THAT 6ATM IS THE RECOMMENDED POST-TREATMENT PRESSURE. THE COMPLAINT DEVICE WAS RETURNED BY THE REPORTING PARTY. THE REPORTED FAILURE (DIFFICULT TO REMOVE FROM TREATMENT SITE) COULD NOT BE CONFIRMED. HOWEVER, KINKS IN THE SHAFT WERE NOTED, ALONG WITH A TEAR ON THE SHAFT. THE ROOT CAUSE FOR THE KINKS AND TEAR IN THE SHAFT CAN LIKELY BE ATTRIBUTED TO THE RESISTANCE ENCOUNTERED DURING REMOVAL OF THE DEVICE. NO LOSS OF PRESSURE WAS ENCOUNTERED DURING THE PROCEDURE. THE ISSUES WITH REMOVING THE CATHETER FROM THE TREATMENT SITE CAN BE ATTRIBUTED TO THE BALLOON GETTING CAUGHT ON THE STENT AS A RESULT OF OFF LABEL USE. 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

    THE AREA OF TREATMENT WAS AN OLD RE-STENOSED STENT IN THE OSTIAL/PROXIMAL/MID CIRCUMFLEX ARTERY. IT IS TO BE NOTED THAT THE C2 IVL IS INDICATED ONLY FOR TREATMENT OF DE NOVO ARTERIES AND TREATMENT OF A RE-STENOSED STENT IS OUTSIDE OF THE INSTRUCTIONS FOR USE. THE PROCEDURE WAS DONE THROUGH THE RADIAL APPROACH, 6F GUIDE CATHETER (VODA LEFT 3.5), RUNTHROUGH WIRE. THE LESION WAS PREDILATED WITH A 2.5 X 12 TREK BALLOON. A 4 X 12 C2 CATHETER WAS USED AND 80 PULSES WERE ADMINISTERED TO THE MID/PROX CIRCUMFLEX AREA (IN STENT). ALL PULSES WERE ADMINISTERED AT 4ATM AND THEN THE DEVICE WAS INFLATED TO 10ATM TO DILATE THE AREA OF INTEREST, WHICH IS OUTSIDE THE INSTRUCTIONS FOR USE FOR THE C2 IVL DEVICE. WHEN DEFLATING THE BALLOON THE RADIOLOGY TECH (RT) DID NOT NOTICE ANY BLOOD COMING BACK THROUGH THE SHAFT OR INTO THE INFLATION DEVICE AND THE BALLOON APPEARED TO PERFORM NORMALLY THROUGHOUT USE. UPON REMOVAL OF THE SHOCKWAVE C2 CATHETER, THERE WAS RESISTANCE AS THE BALLOON REACHED THE LEFT MAIN (LM) OSTIUM AND GUIDE CATHETER. THE PHYSICIAN UNSEATED THE GUIDE CATHETER FROM THE LM OSTIUM AND WITHDREW THE C2 CATHETER INTO THE GUIDE CATHETER WHILE IN THE AORTA, WITH SOME RESISTANCE. ONCE THE C2 WAS REMOVED, THE PHYSICIAN AND RT NOTED THAT THE C2 WAS DAMAGED AND THE STENT WAS PULLED OUT ALONG WITH THE CATHETER. THE LESION AREA WAS THEN IMAGED WITH IVUS (VOLCANO) AND TREATED WITH A 4.5 X 12 NC BALLOON CATHETER. THE PHYSICIAN NOTED THAT THE IVUS IMAGES SHOWED THE PROXIMAL/OSTIAL CIRCUMFLEX HAD FREE FLOATING STENT STRUTS WHICH WERE HANGING INTO THE DISTAL LEFT MAIN. THE LM WAS MUCH LARGER SO THE STRUTS WERE NOT APPOSED TO THE VESSEL WALL. SWM IS NOT AWARE OF ANY CATHETER SEPARATION INSIDE THE PATIENT'S BODY. THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766061 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL INC. C2IVL4012 A210607O 00195451000119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O 2.5 X 12 TREK BALLOON - UNKNOWN MFG.| 4.5 X 12 NC BALLOON CATHETER - UNKNOWN MFG.| 6F GUIDE CATHETER (VODA LEFT 3.5)| STENT - UNKNOWN MFG.