BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI FIELDER PTCA GUIDE WIRE

    MDR report key: 4220859 · Received November 3, 2014

    Report

    Report Number
    3003775027-2014-00062
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K052022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: RUNTHROUGH, GUIDE CATH: AL1, SHEATH: 6FR, 7FR, ATHERECTOMY: 1.4 LASER, STENT: 2.5X32 PROMUS ELEMENT, 3.5X19MM GRAFTMASTER. THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: THE DEVICE WAS NOT RETURNED FOR OUR INVESTIGATION. WITH THE PROVIDED INFORMATION, IT COULD NOT BE IDENTIFIED THE PROCESS AND CIRCUMSTANCE HOW THE FIELDER GUIDE WIRE CONTRIBUTED TO THE VESSEL PERFORATION. THE LOT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS AVAILABLE, HOWEVER, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY SINCE ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE RELEASE CRITERIA. THE WARNING SECTION OF THE INSTRUCTIONS FOR USE (IFU) DESCRIBES: ALWAYS ADVANCE AND WITHDRAW THE GUIDE WIRE SLOWLY. OBSERVE GUIDE WIRE MOVEMENT IN THE VESSELS. DO NOT MOVE OR TORQUE A GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP, OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR VESSEL TRAUMAS MAY OCCUR. DAMAGE TO A VESSEL, INCLUDING POSSIBLE VESSEL PERFORATION AS ONE OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS. (B)(4).

    Description of Event or Problem · 1

    HOLD FOR LOISIT WAS REPORTED THAT THE 3.5X19 MM GRAFTMASTER STENT WAS USED TO TREAT A PERFORATION IN THE POSTERIOR DESCENDING ARTERY (PDA) THAT WAS UNDER A DRUG ELUTING STENT THAT HAD BEEN DEPLOYED FOR TREATMENT OF THE PERFORATION; HOWEVER, THIS ALLOWED THE PLACEMENT OF THE GRAFTMASTER STENT INSIDE THAT DEPLOYED STENT. THE SIZE OF THE GRAFTMASTER WAS TOO LARGE FOR THE PDA, BUT WAS THE ONLY ONE THE HOSPITAL HAD IN STOCK. THE STENT IMPLANT WAS CONSERVATIVELY DEPLOYED AT 11 ATMOSPHERES; HOWEVER, THE STENT WAS NOT FULLY DEPLOYED AND THE BALLOON COULD NOT BE REMOVED FROM THE DEPLOYED STENT. THE STENT BALLOON WAS INFLATED AGAIN FOR ANOTHER 1 ATMOSPHERE AND THE STENT WAS DEPLOYED SUCCESSFULLY, ALLOWING SUCCESSFUL REMOVAL OF THE BALLOON FROM THE DEPLOYED STENT. THE GRAFTMASTER SEALED THE PERFORATION SUCCESSFULLY. AN UNKNOWN FIELDER GUIDE WIRE HAD ALSO BEEN MANIPULATED INTO THE SIDE BRANCH OF THE PDA FOR SUPPORT, MANIPULATION OF THE GUIDE WIRE CAUSED A PERFORATION OF THE SIDE BRANCH OF THE PDA. BALLOON INFLATIONS FAILED TO TREAT THIS PERFORATION; THEREFORE, A GELFOAM WAS INJECTED INTO THE BRANCH SHUTTING IT DOWN. THE GUIDE WIRE WAS REMOVED AND ANGIOGRAPHY REVEALED A BRISK FLOW IN THE PDA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701680 ASAHI FIELDER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention