BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERWAND XL INTRODUCER WITH AN EXTENDED DWELL CATHETER

    MDR report key: 7526476 · Received May 18, 2018

    Report

    Report Number
    3009549229-2018-00001
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    March 26, 2018
    Report Date
    April 24, 2018
    Manufacturer
    ACCESS SCIENTIFIC, LLC
    Product Code
    DYB
    UDI-DI
    20859821006104
    PMA / PMN Number
    K162322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PATIENT AT THE (B)(6) MEDICAL CENTER LOCATED AT (B)(6) EXPERIENCED AN ADVERSE EVENT THAT INVOLVED ACCESS SCIENTIFIC, LLC'S PRODUCT, THE POWERWAND XL INTRODUCER WITH AN EXTENDED DWELL CATHETER, MODEL 3FR 6 CM, CATALOG NUMBER 94122. THE DETAILS OF THE EVENT IS DESCRIBED AS FOLLOWS, THE HOSPITAL PICC TEAM WAS NOTIFIED THAT THE DEVICE (CATHETER) BROKE AND REMNANTS OF THE DEVICE (CATHETER) REMAINED IN THE PATIENT'S ARM. THE PATIENT REPORTED THAT THE BREAKAGE OCCURED WHILE THE PATIENT WAS TAKING A SHOWER. THE PATIENT REPORTED HAVING A GEL SUBSTANCE IN HER HAIR FROM A PREVIOUS PROCEDURE THAT OF WHICH SHE WAS TRYING TO REMOVE IN THE SHOWER. WHILE IN THE SHOWER, THE DEVICE (CATHETER) WAS WRAPPED IN AQUA GUARD. WHILE THE PATIENT WAS REMOVING THE GEL SUBSTANCE FROM HER HAIR, THE DEVICE (CATHETER) WAS CAUGHT IN HER HAIR AND THE DEVICE (CATHETER) BROKE APART. IMMEDIATELY AFTER THE INCIDENT HAD OCCURED, THE HOSPITAL'S PICC NURSE EVALUATED THE ARM VIA ULTRASOUND METHOD AND DETERMINED THAT 6 CM OF THE DEVICE (CATHETER) REMAINED SUPERFICIAL IN THE EXPECTED LOCATION WITHIN THE FOREARM. AFTER COLLABORATION FROM PHYSICIANS, THE DEVICE (CATHETER) REMNANTS WERE REMOVED FROM THE PATIENT'S ARM USING LOCAL ANESTHETIC AND THE 'CUT-DOWN' PROCEDURE. THE SURGICAL PROCEDURE WAS PERFORMED BY THE SURGICAL RESIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370382 POWERWAND XL INTRODUCER WITH AN EXTENDED DWELL CATHETER CATHETER INTRODUCER DYB ACCESS SCIENTIFIC, LLC 10117 I720440 20859821006104

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention