BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIGLIDE GUIDEWIRE

    MDR report key: 12771689 · Received November 8, 2021

    Report

    Report Number
    9681834-2021-00195
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    September 21, 2021
    Report Date
    November 8, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K091417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER - UNKNOWN (0YK). EXPIRATION DATE - UNKNOWN DUE TO THE UNKNOWN LOT NUMBER. UDI - UNKNOWN DUE TO UNKNOWN LOT NUMBER (B)(4). IMPLANTED DATE - DEVICE NOT IMPLANTED. EXPLANTED DATE - DEVICE NOT EXPLANTED. MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT RETURNED, THEREFORE THE ANALYSIS OF THE ACTUAL SAMPLE COULD NOT BE PERFORMED, AS IT WAS NOT RETURNED TO ASHITAKA FACTORY. CONCERNING THE NOVEMBER-2020 PRODUCTION (0YK) LOT, REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD CONFIRMED THAT THERE WAS NO PROBLEM IN THEM. CONCERNING THE NOVEMBER-2020 PRODUCTION (0YK) LOT, REVIEW OF THE COMPLAINT RECORD FOUND NO OTHER SIMILAR REPORTS FROM OTHER FACILITIES. ASHITAKA FACTORY ASSURES THE QUALITY OF THIS PRODUCT BY CONDUCTING THOROUGH INSPECTIONS, INCLUDING THE FOLLOWINGS, IN THE PRODUCTION PROCESS. 100% VISUAL INSPECTION IS PERFORMED BEFORE THE PACKAGING PROCESS FOR ANY ANOMALY SUCH AS SCRATCHED IN ITS APPEARANCE. THE OUTER DIAMETER OF THE CORE WIRE IS CONTROLLED TO ASSURE ITS STRENGTH. 100% VISUAL INSPECTION IS PERFORMED IN THE PRODUCT ASSEMBLY PROCESS TO ENSURE THAT THERE ARE NO SCRATCHES OR EXPOSED WIRES. THE CONDITIONS (COATING SPEED, DIPPING TIME) AT THE TIME OF APPLYING THE HYDROPHILIC COAT ARE CONTROLLED. AS A PART OF THE SHIPPING INSPECTIONS, SAMPLING-BASED MEASUREMENT OF THE SURFACE SLIDABILITY AND THE STRENGTH OF THE TIP SECTION AGAINST TENSILE LOAD ARE PERFORMED. BASED ON THE DESCRIPTION OF THE EVENT AND THE INVESTIGATION RESULT, IT WAS ASSUMABLE THAT THE ACTUAL SAMPLE WAS MANIPULATED WHILE THE DISTAL END OF THE CONCURRENTLY USED METAL NEEDLE WAS IN CONTACT WITH THE URETHANE COAT SURFACE OF THE ACTUAL SAMPLE, WHICH RESULTED IN THE PEELING OF URETHANE COAT. HOWEVER, THE DEFINITE CAUSE OF OCCURRENCE COULD NOT BE DETERMINED SINCE THE CONFIRMATION OF THE ACTUAL SAMPLE COULD NOT BE PERFORMED. PLEASE SEE MDR 2243441-2021-00057 FOR THE IMPORTER REPORT. (B)(4).

    Description of Event or Problem · 0

    TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "AN EDS-GUIDED (ENDOSCOPIC ULTRASOUND) BILIARY RENDEZVOUS WITH ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE WAS BEING PERFORMED. A THERAPEUTIC ECHOENDOSCOPE WAS INSERTED AND THE LEFT INTRAHEPATIC BILE DUCT WAS PUNCTURED USING A 19-GAUGE NEEDLE UNDER ENDOSONOGRAPHIC AND RADIOLOGIC GUIDANCE THROUGH A TRANSGASTRIC APPROACH. AN ANGLED VISIGLIDE GUIDEWIRE WAS PASSED ANTEROGRADE THROUGH THE NEEDLE. THE GUIDEWIRE WAS RETRACTED. FLUOROSCOPY REVEALED THAT A FRAGMENT OF THE GUIDEWIRE WAS RETAINED IN THE PATIENT'S LIVER. AN ATTEMPT TO REMOVE THE FRAGMENT OF WIRE DURING THE PROCEDURE WAS UNSUCCESSFUL. THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. DETERMINATION TO REMOVE THE RETAINED WIRE WILL BE MADE IN THE FOLLOW UP APPOINTMENT. THE PATIENT HAS A PRE-EXISTING CONDITION OF HYPERTENSION." ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. THE PATIENT WAS IN STABLE CONDITION. THE PATIENT MAY REQUIRE INTERVENTION TO REMOVE THE WIRE FRAGMENT IN THE FUTURE, HOWEVER AS OF (B)(6) 2021 THEY HAVE NOT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667893 VISIGLIDE GUIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA OL-XA25453M UNK (OYK)

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other NDL EUS FNA FLEX 19GA LOT 27623865