BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 2152284 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04798
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    October 26, 2010
    Report Date
    June 13, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K062186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TEMECULA MFR NUMBER WAS INCORRECTLY USED ON THE INITIAL MEDWATCH REPORT. THE MFR NUMBER FOR (B)(4) IS THE CORRECT NUMBER THAT SHOULD HAVE BEEN USED. A SEPARATE MEDWATCH REPORT IS BEING FILED UNDER THE CORRECT (B)(4) MFR NUMBER FOR THE ASAHI DEVICE. THE ANALYSIS WAS PERFORMED BY (B)(4) INVESTIGATION OF THE GUIDE WIRE COULD NOT BE CONDUCTED BECAUSE IT WAS NOT RETURNED. INVESTIGATION OF THE PRODUCTION RECORD REVEALED NO ANOMALY. BASED ON THE PROVIDED INFORMATION, IT COULD NOT BE DETERMINED OR IDENTIFIED IF THERE WERE ANY PRODUCT TROUBLES INCLUDING COIL STRETCH AND/OR GUIDE WIRE SEPARATION, AND WHAT KIND OF PRODUCT TROUBLE IF THERE WERE ANY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS MANUFACTURED BY (B)(4); HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH RECEIVED REPORTING THE FOLLOWING: "THE SURGEON USED THE OUTBACK RE-ENTRY CATHETER TO RE-ENTER INTO THE PATIENT'S RIGHT SUPERFICIAL FEMORAL ARTERY. IN THE PROCESS ONE OF THE PROWATER WIRES FRACTURED OFF AND WAS THEN DETERMINED TO BE EXTRALUMINAL. SEVERAL ATTEMPTS WERE USED TO MOVE THE CATHETER TIP. ON EXAMINATION BY THE SURGEON OF THE OUTBACK RE-ENTRY CATHETER IT WAS NOTED TO BE UNCOILED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? LEFT COMMON FEMORAL ARTERY RETROGRADE ACCESS. DIAGNOSTIC ABDOMINAL AORTOGRAM. DIAGNOSTIC PELVIC ANGIOGRAM. SELECTIVE OPEN AND OVER RIGHT LOWER EXTREMITY ANGIOGRAM WITH RUNOFF. THIRD ORDER CATHETER PLACEMENT IN THE RIGHT PERONEAL ARTERY. OUTBACK RE-ENTRY CATHETER PLACEMENT AND RECANNULIZATION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. RECANNULIZATION OF RIGHT TIBIAL PERONEAL TRUNK CHRONIC TOTAL OCCLUSION. ANGIOPLASTY RIGHT SUPERFICIAL FEMORAL ARTERY, RIGHT POPLITEAL ARTERY, RIGHT TIBIAL PERONEAL TRUNK AND RIGHT PERONAL ARTERY. COMPLETION ANGIOGRAPHY, INSTALLATION OF 200MCG OF NITROGLYCERIN AND COMPLETION RUNOFF. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 090722A481

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention GUIDE CATH: CORDIS OUTBACK RE-ENTRY