BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI FIELDER FC

    MDR report key: 9177222 · Received October 10, 2019

    Report

    Report Number
    3003775027-2019-00164
    Event Type
    Injury
    Date Received
    October 10, 2019
    Date of Event
    September 27, 2019
    Report Date
    September 27, 2019
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327063319
    PMA / PMN Number
    K063819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ASAHI INTECC HAS DETERMINED THAT THE DATE RECORDED IN BLOCK B4 "DATE OF THIS REPORT" WAS ERRONEOUSLY REPORTED AS THE DATE THE REPORT WAS SUBMITTED RATHER THAN THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY. CORRECTIVE ACTION HAS BEEN TAKEN TO CLARIFY WHICH DATE SHOULD BE PROVIDED IN THE REPORT. THIS SUPPLEMENTAL REPORT IS INTENDED ONLY TO CORRECT THE DATE PROVIDED IN BLOCK B4 TO REFLECT THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT TO THE COMPANY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: (B)(4). THE RETURNED FIELDER FC WAS BENT AT APPROXIMATELY 140MM FROM THE TIP. THE ELONGATED COIL WIRE WAS EXPOSED FOR APPROXIMATELY 25-40MM FROM THE TIP ALONG WITH RUPTURE OF THE POLYMER JACKET. THE CORE WIRE WAS NOT OBSERVED UNDER THE ELONGATED COIL WIRE; THE CORE WIRE WAS FRACTURED. TO OBSERVE THE FRACTURED CORE, THE POLYMER JACKET WAS REMOVED. THE CORE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 2MM DISTAL TO THE MID SOLDER (FIXES THE COIL WIRE ONTO THE CORE WIRE) ORIGINALLY LOCATED AT 25MM FROM THE TIP. A BEND WAS OBSERVED ON EACH SIDE OF THE CORE FRACTURE. SCANNING ELECTRON MICROSCOPE WAS USED TO OBSERVE THE CORE FRACTURE. ADDITION TO THE BENDS NEAR THE FRACTURE SITE, TWIST PATTERN WAS OBSERVED ON BOTH FRACTURE SURFACES. THESE FINDINGS SUGGESTED THAT BENDING STRESS AS WELL AS TORSION HAD CONTRIBUTED TO THE CORE FRACTURE. IN SUMMARY, THE CORE WIRE WAS FRACTURED AT APPROXIMATELY 23MM FROM THE WIRE TIP AND THE COIL WIRE ELONGATION ORIGINATED FROM THE TIP SOLDER. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT BENDING STRESS AND TORSION GENERATED WITH WIRE MANIPULATION WERE ACCUMULATED ON THE GUIDE WIRE LIKELY WHEN WIRE MOVEMENT WAS RESTRICTED DUE TO ANATOMICAL CONDITION. WHEN THE ACCUMULATED STRESS EXCEEDED THE PRODUCT'S DESIGN LIMIT, IT CAUSED THE CORE WIRE TO FRACTURE. ELONGATION OF THE COIL WIRE AND RUPTURE OF THE POLYMER JACKET WERE PROBABLY CAUSED WHEN TENSILE STRESS WAS GENERATED WITH WIRE REMOVAL. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. BECAUSE DAMAGE OBSERVED ON THE POLYMER JACKET WAS SEVERE, POTENTIALITY COULD NOT BE COMPLETELY RULED OUT THAT SOME FRAGMENT(S) MIGHT BE LEFT IN THE PATIENT. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS THE RESISTANCE. TORQUING OR PUSHING A GUIDEWIRE AGAINST RESISTANCE MAY CAUSE GUIDEWIRE DAMAGE AND/OR GUIDEWIRE TIP SEPARATION OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKING OF THE GUIDEWIRE TIP. IF GUIDEWIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDEWIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION; [WARNINGS] IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDEWIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDEWIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDEWIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL; AND, [MALFUNCTION AND ADVERSE EFFECTS] BREAKAGE OF THE GUIDE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A 75-90% STENOSIS IN THE LEFT ASCENDING ARTERY (LAD). AN ASAHI GUIDE WIRE FIELDER FC WAS USED TO PROTECT THE D1 BRANCH. AFTER TREATING THE LAD LESION, THE GUIDE WIRE WAS REMOVED WHEN ELONGATION OF THE COIL WIRE OCCURRED AT ABOUT 3CM FROM THE WIRE TIP AND THE GUIDE WIRE BARELY BECAME SEPARATED. A STENT WAS DEPLOYED AND THE BLOOD FLOW WAS SUCCESSFULLY REESTABLISHED. THE PHYSICIAN COMMENTED THAT HE MIGHT HAVE ROTATED THE GUIDE WIRE SO MUCH THAT THE GUIDE WIRE BROKE. THERE WERE NO ADVERSE PATIENT EFFECTS SECONDARY TO THE WIRE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968863 ASAHI FIELDER FC PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. N/A 190511A58A 04547327063319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other