BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE GUIDWIRE

    MDR report key: 11811039 · Received May 12, 2021

    Report

    Report Number
    9681834-2021-00052
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    March 22, 2021
    Report Date
    May 12, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    UDI-DI
    04953170282782
    PMA / PMN Number
    K091417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. HOWEVER, THE USER FACILITY PROVIDED A PICTURE. FROM THE PICTURE, THE ACTUAL DEVICE SEEMED TO HAVE BEEN INSERTED IN THE HOLDER. IT WAS IMPOSSIBLE TO CONFIRM THE STATE OF THE DISTAL TIP SECTION. THE WIRE CLIP WAS FOUND ATTACHED TO THE HOLDER. REPRODUCTIVE TESTING WAS PERFORMED, REFERRING TO THE STATE OF THE ACTUAL SAMPLE IN THE PROVIDED PICTURE, ABOUT 50 MM FROM THE DISTAL END OF A GUIDEWIRE SAMPLE WAS PINCHED FIRMLY, AND THEN PULLED FROM THE HOLDER, WHILE THE WIRE CLIP WAS STILL ATTACHED TO THE HOLDER. AS A RESULT, THE URETHANE COATING OF DISTAL 50 MM WAS PEELED OFF. REGARDING THE INVOLVED PRODUCT CODE/NOVEMBER 2020 PRODUCTION LOT (0YK), REVIEW OF THE MANUFACTURING RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD CONFIRMED NO ANOMALY RECORDED IN THEM. IT IS LIKELY THAT THE URETHANE COATING WAS PEELED OFF 50 MM FROM THE DISTAL END DUE TO AN EXCESSIVE TENSILE LOAD HAVING BEEN APPLIED TO THE ACTUAL SAMPLE DURING REMOVAL FROM THE HOLDER. IN ADDITION, A REPRODUCTIVE TEST SHOWED THAT THERE WAS A POSSIBILITY THAT A TENSILE LOAD COULD HAVE BEEN APPLIED TO THE GUIDEWIRE WHEN THE GUIDEWIRE WAS PULLED FROM THE HOLDER WHILE THE WIRE CLIP WAS ATTACHED TO THE HOLDER. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT PRE-TREATMENT, WHEN THE CUSTOMER LOOKED AT A SET OF SINGLE USE GUIDEWIRE, THEY FOUND THAT THE COATING WAS DAMAGED ABOUT 5CM. THEY DID NOT USE THE WIRE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707273 SINGLE USE GUIDWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA NA UNK 04953170282782

    Patients

    Seq Age Sex Outcome Treatment
    1