BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASAHI FIELDER XT PTCA GUIDE WIRE

    MDR report key: 5658186 · Received May 16, 2016

    Report

    Report Number
    3003775027-2016-00082
    Event Type
    Death
    Date Received
    May 16, 2016
    Date of Event
    April 14, 2016
    Report Date
    October 11, 2016
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K072431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 DEVICE WAS REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4) UNIQUE DEVICE IDENTIFIER (UDI): THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WAS NOT PROVIDED. THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: INVESTIGATION OF THE PRODUCTION RECORD COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS AVAILABLE. INVESTIGATION BASED ON THE PROVIDED INFORMATION DID NOT SHOW THAT THERE WAS A CONTRIBUTION OF THE FIELDER XT GUIDEWIRE TO THE REPORTED VESSEL PERFORATION. IFU DESCRIBES AS WARNING: OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR VESSEL TRAUMA MAY OCCUR AS POSSIBLE MALFUNCTION AND ADVERSE EFFECTS: CARDIAC PERFORATION, CARDIAC TAMPONADE DUE TO VESSEL PERFORATION. POSSIBILITY OF OCCURRENCE OF COMPLICATIONS INCLUDING SERIOUS INJURY TO THE PATIENT OR DEATH. ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA. THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. (B)(4), REGISTRATION NUMBER: (B)(4). (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ANTERIOR WALL MYOCARDIAL INFARCTION AND ELECTROCARDIOGRAM SHOWED 100% OCCLUSION OF THE MID-LEFT ANTERIOR DESCENDING ARTERY (LAD). A FIELDER XT GUIDE WIRE WAS POSITIONED AND A PERFORATION WAS NOTED FOLLOWED BY CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED AND A GRAFTMASTER STENT WAS SUCCESSFULLY IMPLANTED. THE PATIENT EXPERIENCED HYPOTENSION AND WAS TREATED WITH MEDICATION AND WENT INTO CARDIAC ARREST WITH PULSELESS ELECTRICAL ACTIVITY. PROLONGED CARDIOPULMONARY RESUSCITATION RESULTED IN NO IMPROVEMENT IN STATUS AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310873 ASAHI FIELDER XT PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death