BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWISTER PLUS ROTATABLE RETRIEVAL DEVICE

    MDR report key: 4080799 · Received September 5, 2014

    Report

    Report Number
    MW5038114
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT COLONOSCOPY ON (B)(6) 2014. THE TWISTER PLUS NET ROTATABLE RETRIEVAL DEVICE WAS USED TO RETRIEVE GASTRIC POLYPS DURING THE PROCEDURE. THE DEVICE WAS USED MULTIPLE TIMES TO RETRIEVE GASTRIC POLYPS (X3). DURING REMOVAL OF THE LAST GASTRIC POLYP THE NET WAS DEPLOYED, HOWEVER, IT WOULD NOT RETRACT BACK INTO THE SHEATH. THE DEVICE WAS PULLED THROUGH THE SCOPE AND THE OPENED NET DETACHED AND REMAINED IN THE GASTRIC BODY. THE OPEN NET WAS REMOVED WITH A DIFFERENT RETRIEVAL DEVICE AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543272 TWISTER PLUS ROTATABLE RETRIEVAL DEVICE ENDOSCOPIC RETRIEVAL DEVICE GCJ BOSTON SCIENTIFIC H13091602

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention