BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 2170677 · Received July 21, 2011

    Report

    Report Number
    3003775027-2011-00028
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE REPORTED KINK AND THE REMOVAL DIFFICULTY OF THE GUIDE WIRE IS PRESUMED TO BE DUE TO THE KINK OF THE DILATATION CATHETER USED IN COMBINATION, AND/OR THE CONTINUED USE OF THE DEVICES AGAINST THE RESISTANCE THAT WAS ANTECEDENTLY RECOGNIZED. THE WARNING SECTION OF THE INSTRUCTIONS FOR USE STATES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. SEPARATION OR BREAKAGE OF GUIDE WIRE ARE LISTED AS POSSIBLE COMPLICATIONS AND ADVERSE EVENTS. PRODUCTS ARE ALL INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS, AND ONLY THE PASSED PRODUCTS ARE SHIPPED; THEREFORE, THE DEVICE IN QUESTION IS CONSEQUENTLY CONSIDERED FREE FROM DEFICIENCY. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. (B)(4). THE ARMADA DILATATION CATHETER IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 99% DIFFUSED RIGHT ANTERIOR TIBIAL ARTERY. AFTER PLACING A PROWATER GUIDE WIRE, THE ARMADA BALLOON CATHETER WAS ADVANCED, BUT RESISTANCE WAS MET AND AS IT WAS PUSHED FORWARD TO GET TO THE LESION, THE END OF THE CATHETER PROLAPSED INTO THE PERINEAL ARTERY. THE BALLOON WAS INFLATED TWICE TO 12 ATMOSPHERES IN THE PROLAPSED STATE. THE DECISION WAS MADE TO EXCHANGE THE PROWATER GUIDE WIRE FOR A MORE SUPPORTIVE GUIDE WIRE, BUT AS THE PROWATER WAS REMOVED, RESISTANCE WAS MET (WITH THE CATHETER) AND ONCE IT WAS REMOVED, IT WAS OBSERVED TO BE KINKED AT THE AREA WHERE THE BALLOON HAD PROLAPSED. AN ATTEMPT WAS MADE TO ADVANCE A GRANDSLAM GUIDE WIRE, BUT RESISTANCE WAS AGAIN MET WITH THE ARMADA, SO IT WAS REMOVED. THE ARMADA WAS THEN REMOVED FROM THE PATIENT TO BE FLUSHED. WHILE FLUSHING THE LUMEN, FLUID WAS NOTED COMING OUT OF THE BALLOON PORT. A NEW ARMADA BALLOON CATHETER WAS USED SUCCESSFULLY WITH THE GRANDSLAM GUIDE WIRE TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR DILATATION CATHETER: ARMADA