BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDEWIRE

    MDR report key: 4780347 · Received May 19, 2015

    Report

    Report Number
    9681834-2015-00079
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 21, 2015
    Report Date
    May 19, 2015
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SECTION WAS COMPLETED BY THE MANUFACTURER PER CFR 803.52(F) (11) BECAUSE THE INFORMATION WAS NOT INITIALLY COMPLETED BY THE USER FACILITY. THE ACTUAL SAMPLE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION AND THE INVOLVED LOT NUMBER IS UNKNOWN. THEREFORE THE INVESTIGATION IS BASED UPON THE USER FACILITY INFORMATION AND THE EVALUATION OF THE CURRENT PRODUCT OF THE INVOLVED PRODUCT CODE. VISUAL INSPECTION OF THE CURRENT PRODUCT SAMPLE REVEALED NO ANOMALIES OR DEFECTS. MAGNIFYING INSPECTION OF THE OUTER SURFACE FOUND NO ABNORMALITIES OR DEFECTS. THE OUTSIDE DIAMETER WAS MEASURED AND CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD, SHIPPING INSPECTION RECORD AND COMPLAINT FILES. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE COMPLAINT DESCRIPTION THAT THE BILE DUCT AND CYSTIC WAS TORTUOUS AND STENOSED SEVERELY, AS A CAUSE OF OCCURRENCE, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS SUBJECTED TO EXTERNAL FORCES, SUCH AS SOME BENDING FORCES AND BECAME FRACTURED AT THE SEGMENT. WITH NO RETURN OF THE ACTUAL SAMPLE TO EVALUATE, THE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED DEFINITELY. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATEMENTS SUCH AS THE FOLLOWING: DO NOT INSERT THE INSTRUMENT INTO THE ENDOSCOPE OR ENDO THERAPY ACCESSORY UNLESS MOVEMENTS OF THE INSTRUMENT CAN BE OBSERVED UNDER CLEAR ENDOSCOPIC OR X-RAY IMAGE. IF YOU CANNOT SEE THE DISTAL END OF THE INSERTION POTION IN THE ENDOSCOPIC OR X-RAY IMAGE, DO NOT USE THE INSTRUMENT. OTHERWISE UNINTENDED MOVEMENTS OF THE INSTRUMENT COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE, INSTRUMENT AND/OR ENDO THERAPY ACCESSORY. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A FRACTURE WITH THE SINGLE USE GUIDEWIRE DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: THE INVOLVED PHYSICIAN WAS TRYING TO ADVANCE THE ACTUAL SAMPLE THROUGH THE BILIARY DUCT AND CYSTIC DUCT; WHICH WERE ACUTELY CURVED AND SEVERELY STENOSED; THE PHYSICIAN WAS ABLE TO CROSS THE STENOSIS IN THE BILIARY DUCT; WHEN THE ACTUAL SAMPLE WENT INTO THE CYSTIC DUCT THE PHYSICIAN TRIED TO PULL IT OUT OF THE DUCT; IT THEN BECAME FRACTURED; THE DISTAL SEGMENT OF THE SHAFT APPROXIMATELY FIVE TO SIX MILLIMETERS FROM THE DISTAL END REMAINED IN THE DUCT; AND DUE TO THE SEVERE CURVATURE AND STENOSIS OF THE DUCTS, IT WAS DECIDED NOT TO RETRIEVE THE FRACTURED PIECE FROM THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326586 SINGLE USE GUIDEWIRE GUIDEWIRE KOG TERUMO CORPORATION, ASHITAKA N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other