BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 2972075 · Received February 21, 2013

    Report

    Report Number
    3005099803-2013-00905
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.(B)(4):THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A PANCREATIC CYST DRAINAGE ON (B)(6), 2013. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE JAGWIRE WAS INSERTED THROUGH AN EXPECT 19GA NEEDLE. WHILE WITHDRAWING FROM THE PACREATIC CYST, THE JAGWIRE WAS MISTAKENLY CONTACTED TO THE DISTAL END OF THE NEEDLE. THE ENTIRE DISTAL TIP AND SOME PTFE COATING WAS DETACHED FROM THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH THE SAME TWO DEVICES. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS STABLE. THE PHYSICIAN PLANS TO RETRIEVE THE DETACHED FRAGMENT USING A BASKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77172 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK548

    Patients

    Seq Age Sex Outcome Treatment
    1