BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVOLUTION 45MHZ IVUS IMAGING CATHETER

    MDR report key: 5010049 · Received August 14, 2015

    Report

    Report Number
    2939520-2015-00048
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 21, 2015
    Manufacturer
    VOLCARICA S.R.L.,
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO VOLCANO POLICY. THE REVOLUTION CATHETER WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION REVEALED THE SERIAL NUMBER OF THE DEVICE COULD NOT BE CONFIRMED SINCE THE IMAGING CORE ASSEMBLY AND TELESCOPE ASSEMBLY (INCLUDING THE PIM CONNECTOR) WERE MISSING. THE PROXIMAL SHAFT HAD BEEN SEVERED NEAR THE JOINT BETWEEN THE TELESCOPE AND THE PROXIMAL SHAFT. A SLIGHT KINK WAS OBSERVED AT THE PROXIMAL SHAFT LOCATED 150MM FROM THE BROKEN POINT. THE ENTIRE DISTAL SHAFT WAS ELONGATED AND THREE MAJOR ELONGATIONS WERE NOTED. BEGINNING FROM THE DISTAL TIP ASSEMBLY TO THE PROXIMAL SHAFT BOND AND MOVING TOWARD THE DISTAL TIP, STRETCHING WAS OBSERVED BETWEEN 74MM AND 80MM, BETWEEN 317 AND 323MM (AT THE DISTAL SHAFT WINDOW), AND BETWEEN 342MM AND 350MM (AT THE DISTAL TIP). A TEAR OR FLARE WAS OBSERVED IN THE DISTAL END OF THE MONORAIL. DRIED BLOOD WAS OBSERVED ALONG THE DISTAL SHAFT PROXIMAL SECTION AND AT THE DISTAL SHAFT WINDOW WHERE THE FLUSHING EXIT PORT IS LOCATED. ALSO, A STICKY RESIN-LIKE MATERIAL AND SOME PARTICULATES WERE NOTED ON SOME AREAS AT THE PROXIMAL SHAFT AS WELL AS ON THE DISTAL SHAFT. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED ADVERSE EVENT. TO DATE, NO OTHER COMPLAINTS WERE REPORTED FOR THIS SAME ADVERSE EVENT W/IN THIS LOT.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT ON (B)(6) 2015 HE HAD PLANNED TO PERFORM A THERAPEUTIC PCI IN AN (B)(6) MALE PATIENT, WHO HAD A PCI PERFORMED AT THE HOSPITAL ON (B)(6) 2015, WITH A 2.75 X 24MM DRUG ELUTING STENT (TERUMO, ULTIMASTER) IN THE LAD. THE PATIENT HAD SIGNIFICANT CAD IN THE LCX AND RCA. THE PATIENT CONTINUED TO COMPLAIN OF CHEST PAIN. HE PERFORMED ANGIOPLASTY VIA RADIAL APPROACH (6F). ANGIO REVEALED UNDER DEPLOYED DES MID LAD WITH HEAVILY CALCIFIED LAD. CLINICIAN CROSSED LAD DES WITH AN ASAHI SION BLUE J GUIDEWIRE AND DILATED WITH DES 2.5 X 15 NC BALLOON, FOLLOWED BY REPEATED BALLOON ANGIOPLASTY TO LAD AND DES WHICH WOULD NOT FULLY EXPAND. PHYSICIAN DECIDED TO PERFORM INTRA VASCULAR IMAGING OF THE LAD AND DES WITH VOLCANO REVOLUTION IVUS TO CHECK FOR DISTAL VESSEL CALCIFICATION. HE HAD DIFFICULTY WITH IVUS, PERFORMED TO MID-PROXIMAL LAD TO LM AND WAS UNABLE TO ADVANCE IVUS CATHETER DISTALLY. WHEN ATTEMPTING TO RETRACT THE REVOLUTION CATHETER, IT COULD NOT BE RETRACTED. PHYSICIAN THEN ATTEMPTED SECOND ACCESS VIA A RIGHT FEMORAL APPROACH AND WAS UNABLE TO WIRE PAST THE IVUS CATHETER DESPITE BALLOON SUPPORT AND TWIN PASS SUPPORT OF THE DIAGONAL BRANCH. ANGIOGRAPHICALLY STENT APPEARANCES APPEAR DEFORMED IN LAD. PHYSICIAN THEN ATTEMPTED TO RETRACT THE IVUS CATHETER WITH DEEP GUIDE CATHETER ENGAGEMENT, WHICH RESULTED IN DISSECTION OF PROXIMAL LAD. PATIENT WAS HEMODYNAMICALLY STABLE. PHYSICIAN CONSULTED WITH A CARDIO-THORATIC SURGEON COLLEAGUE AT (B)(6) HOSPITAL AND PATIENT WAS TRANSFERRED TO THIS HOSPITAL WITH FURTHER ATTEMPTS TO REMOVE THE IVUS VIA FEMORAL APPROACH, WHICH WERE UNSUCCESSFUL AS CATHETER WAS TRAPPED IN THE DES. PATIENT HAD EMERGENCY CABG SURGERY TO LAD TO REMOVE THE DES AND IVUS CATHETER. DEVICE WAS BROKEN TO FACILITATE EXTRACTION. PATIENT IS NOW STABLE POST OPERATIVELY, WITH PLANNED DISCHARGE BACK TO THE (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538027 REVOLUTION 45MHZ IVUS IMAGING CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCARICA S.R.L., 89000 0035 50036996

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R