BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 2432974 · Received January 11, 2012

    Report

    Report Number
    2939520-2012-00006
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 6, 2011
    Report Date
    December 13, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MFG DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MFG RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR GUIDE WIRE ENTANGLEMENT WITHIN THIS LOT. A GUIDE WIRE MOVEMENT TEST WAS PERFORMED AND THERE WERE NO OBSTRUCTIONS WITHIN THE MONORAIL. A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED AND ALL PARTS WERE FOUND TO BE PRESENT AND INTACT. TEAR IN THE DISTAL SHAFT AT THE EXIT PORT WAS OBSERVED. THE DAMAGE APPEARS TO BE CONSISTENT WITH THE REPORT OF GUIDE WIRE ENTANGLEMENT. THE GUIDE WIRE WAS NOT RETURNED FOR EVAL, SO IT IS NOT POSSIBLE TO DETERMINE WHAT CAUSED THE TEAR. THE DEVICE WAS TESTED FOR ITS FUNCTIONALITY AND PASSED. NO MFG DEFECT WAS OBSERVED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE OF GUIDE WIRE ENTANGLEMENT. THE IFU WARNING STATES "DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED." IN ADDITION THE IFU CAUTION STATES: "IF THE CATHETER IS ADVANCED TOO NEAR THE END OF THE GUIDE WIRE, ADVANCE THE GUIDE WIRE WHILE HOLDING THE IMAGING CATHETER STEADY. IF THIS FAILS, WITHDRAW THE CATHETER AND GUIDE WIRE TOGETHER." UPON GUIDE WIRE ENTRAPMENT, THE PHYSICIAN FOLLOWED THE IFU AND REMOVED THE CATHETER AND GUIDE WIRE TOGETHER AS ONE UNIT. A DIFFERENT TYPE OF CATHETER AND NEW GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. NO INJURY OR OTHER ADVERSE EVENT WAS REPORTED. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED AT THE BEGINNING OF THE CASE AS THE IVUS CATHETER WAS INSERTED OVER A GUIDEWIRE THROUGH A 6FR GUIDE CATHETER WITH NO PROBLEM. UPON INSERTION INTO THE FEMORAL ARTERY AND AFTER PULLBACK, THE GUIDEWIRE AND THE IVUS CATHETER "GOT STUCK". THE PHYSICIAN WITHDRAW THE GUIDEWIRE AND THE IVUS CATHETER FROM THE GUIDE CATHETER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF IVUS CATHETER AND A NEW GUIDEWIRE. NO ADVERSE EVENTS WERE EXPERIENCED BY THE PT AND THEY WERE RELEASED FROM THE HOSP ACCORDING TO THE TREATMENT PLAN. THE PT'S CONDITION "TODAY IS OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER DIAGNOSTIC INTRAVASCULAR CATHETER OBJ VOLCANO CORPORATION 89000 035 04812

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: GRAND SLAM| GUIDE CATHETER: LAUNCHER 6FR (B)(4)