BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMEWIRE PRESSURE GUIDEWIRE

    MDR report key: 1620165 · Received March 1, 2010

    Report

    Report Number
    2939520-2010-00012
    Event Type
    Other
    Date Received
    March 1, 2010
    Date of Event
    January 1, 2010
    Report Date
    February 15, 2010
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DXO
    PMA / PMN Number
    K070487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRIMEWIRE DEVICE WAS RETURNED TO VOLCANO WITHOUT THE DEVICE CONNECTOR OR DEVICE PACKAGING, SO IDENTIFICATION OF THE DEVICE LOT NUMBER, SERIAL NUMBER, MFG DATE, OR EXP DATE WAS NOT POSSIBLE. BECAUSE WE WERE UNABLE TO IDENTIFY THE DEVICE, WE WERE UNABLE TO CHECK EITHER THE MFG RECORDS OR THE COMPLAINT HISTORY FOR THIS LOT. THE COMPLAINT DEVICE WAS RETURNED TO VOLCANO FOR EVAL AND A VISUAL INSPECTION WAS PERFORMED. THE FOLLOWING WAS OBSERVED: THE DISTAL CONDUCTIVE BAND WAS BENT AT A 90 DEGREES ANGLE. THE SENSOR AND DISTAL TIP DOME WERE UNDAMAGED AND INTACT. THE PROXIMAL COIL WAS SEVERELY CURLED OVER ON ITSELF. THIS TYPICALLY OCCURS WHEN THE DEVICE EXPERIENCES A SERIES OF STRETCHING AND COMPRESSION WHICH CAN CAUSE THE CORE WIRE TO CURL. NO STRETCHING OF THE EXTERNAL COIL WAS OBSERVED. NO PARTS OF THE DEVICE HAD SEPARATED OR WERE MISSING. THE ANGIOSCULPT BALLOON CATHETER WAS RETURNED TO ANGIOSCORE FOR FAILURE ANALYSIS SO IT WAS NOT AVAILABLE FOR EVAL BY VOLCANO. THE PRIMEWIRE DEVICE WAS TOO DAMAGED TO BE FUNCTIONALLY TESTED. THE IFU STATES "NEVER ADVANCE, TORQUE,OR RETRACT A GUIDE WIRE WHICH MEETS SIGNIFICANT RESISTANCE." WHEN THE PHYSICIAN FELT RESISTANCE, HE FOLLOWED THE IFU AND REMOVED THE PRIMEWIRE AND CATHETER TOGETHER AS A SINGLE UNIT. THERE WAS NO REPORT OF PT INJURY OR AN ADVERSE EVENT. IT IS VOLCANO'S POLICY TO REPORT ALL EVENTS REQUIRING EXCHANGE OF A GUIDEWIRE TO THE FDA. THIS REPORT IS FOR NOTIFICATION PURPOSES ONLY.

    Description of Event or Problem · 1

    A VOLCANO PRIMEWIRE WAS USED AND THE WIRE WORKED AS INTENDED FOR THE FFR PORTION OF THE PROCEDURE. HOWEVER, AS THE CASE MOVED INTO AN INTERVENTIONAL PROCEDURE, THE PRIMEWIRE WAS USED AS A GUIDE WIRE. AN ANGIOSCULP .014 BALLOON WAS USED TO PRE-DILATE A LESION. AFTER INFLATION AND UPON TRYING TO RETRIEVE THE BALLOON, THE BALLOON WOULD NOT TRACK OFF OVER THE WIRE. WHEN EXTRA FORCE WAS APPLIED, THE WIRE STRETCHED AND BEGAN TO UNCOIL AND UNRAVEL AT THE DISTAL PORTION. THE PHYSICIAN REMOVED THE WIRE AND BALLOON TOGETHER AND USED A DIFFERENT GUIDE WIRE TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED. THIS IS BEING REPORTED AS A NOTIFICATION ONLY. IT IS VOLCANO'S POLICY TO REPORT ALL CASES WHERE A POTENTIAL VOLCANO DEVICE ISSUE CAUSES REMOVAL OR EXCHANGE OF THE GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE PRESSURE GUIDEWIRE TRANSDUCER, PRESURE, CATHETER TIP DXO VOLCANO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other