BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION

    MDR report key: 1395123 · Received March 12, 2009

    Report

    Report Number
    2939520-2009-00009
    Event Type
    Other
    Date Received
    March 12, 2009
    Date of Event
    January 29, 2009
    Report Date
    March 13, 2009
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO INJURY TO PT OR USER. (B)(4). THIS RECORD WAS DETERMINED TO BE A REPORTABLE EVENT ON 2/17/2009. INVESTIGATION OF THE DEVICE SHOWED THE CATHETER TO BE INTACT THAT IT REMAINED IN ONE PIECE WITH NO PORTIONS DETERMINED TO BE MISSING. IT APPEARS THAT THE WIRE WAS ABLE TO TEAR THROUGH THE MONORAIL SECTION JUST PROXIMAL TO THE POLYIMIDE RING; HOWEVER, THE WIRE DID NOT MAKE IT TO THE POLYIMIDE BAND WHICH PREVENTS TEAR-OUT AND/OR SEPARATION OF THE DEVICE AT THAT LOCATION. THE DISTAL TIP OF THE CATHETER WAS INSPECTED, AND THERE WERE NO OBSERVED PROCESS OR WORKMANSHIP DEFECTS FOUND. POSSIBLE CAUSES OF THE ISSUE IS - GUIDE CATHETER IS NOT PROPERLY SEATED AT THE OSTIUM OR DISTAL TIP OF THE CATHETER IS ADVANCED NEAR THE FLOPPY TIP OF THE GUIDEWIRE. THE PT DID NOT SUFFER ANY ADVERSE EVENT DUE TO THIS ISSUE AS ALL DEVICES WERE SUCCESSFULLY PULLED OUT OF THE PT AS A UNIT. THE GUIDEWIRE WAS NOT RETURNED AND WAS NOT ANALYZED WITH THIS INVESTIGATION.

    Description of Event or Problem · 1

    THE REVOLUTION CATHETER HAD A BIT OF RESISTANCE CROSSING A LESION DURING PRE STENT IVUS IMAGING WITHOUT ANY PROBLEM WITH IMAGING. THE LESION WAS DILATED WITH A STENT DEVICE AND SOME RESISTANCE WAS FELT. THE REVOLUTION CATHETER WAS THEN INSERTED IN THE ARTERY A SECOND TIME. A LOT OF RESISTANCE WAS FELT AS THE CATHETER WAS PULLED BACK AROUND THE LESION POST STENTING. THUS, DR DECIDED TO STOP USING THE REVOLUTION CATHETER AND TRIED TO PULL IT OUT OF THE PT'S BODY, BUT WAS NOT SUCCESSFUL - THE CATHETER WAS STUCK AT THE LESION. DR ATTEMPTED TO REMOVE THE CATHETER AND GUIDE WIRE (AND GUIDE CATHETER) TOGETHER, BUT HAD DIFFICULTY. TAKING A BIT OF TIME, THE WHOLE SYSTEM WAS SUCCESSFULLY PULLED OUT OF THE PT'S BODY. IT WAS FOUND THAT THE REVOLUTION CATHETER HAD TANGLED WITH THE GUIDE WIRE. THE FLOPPY SECTION OF THE GW COIL GOT CAUGHT IN THE GW EXIT PORT OF REVOLUTION AND WAS SEPARATED FROM THE REST OF THE GW. THE REVOLUTION CATHETER AND THE GUIDE WIRE COULD NOT BE SEPARATED, SO BOTH PRODUCTS WERE SENT TO ST JUDE MEDICAL (B)(4). NOTHING REMAINED IN THE ARTERY AND NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORPORATION 89000 035 02686

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: NEO'S ROUTE BY ST JUDE| STENT DEVICE: CYPHER 3.5*23| GUIDE CATHETER: HEARTRAIL SL3.5 TERUMO