BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET XVG CUS CATHETER

    MDR report key: 4648077 · Received March 27, 2015

    Report

    Report Number
    2183460-2015-00027
    Event Type
    Other
    Date Received
    March 27, 2015
    Date of Event
    February 2, 2015
    Report Date
    March 6, 2015
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT ANALYSIS RECEIVED AN EXAMINED THE RETURNED XVG CATHETER. VISUAL EXAMINATION SHOWED THAT THE CATHETER TIP WAS MISSING. THE REPORTED PROBLEM OF THE TIME BREAK OFF WAS CONFIRMED.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A PT HAD UNDERGONE AN EXTREMITY REVASCULARIZATION ND THE ACCESS SITE WAS CLOSED WITH AN ABBOTT PERCLOSE SUTURE DEVICE. THE SITE REPORTED THAT THE ENTIRE VESSEL HAD SHUT DOWN AFTER THE PERCLOSE DEVICE WAS INSERTED ACCESS TO THE VESSEL WAS RE-ESTABLISHED BY PUNCTURING THROUGH THE PERCLOSE SUTURE. AN EV3 SPIDER FILTER WIRE ALONG WITH AN ANGIOJET XVG THROMBECTOMY CATHETER WAS USED TO REMOVE THE CLOT. THE SITE REPORTED THAT THE XVG WAS INSERTED WITH DIFFICULTY AND DID NOT COMPLETELY ADVANCED. WHEN WITHDRAWING, THE XVG BECAME CAUGHT AND THE TIP WAS TORN OFF OF THE CATHETER. THE TIP REMAINED ON THE GUIDE WIRE AND WAS CAPTURED IN THE FILTER. IT WAS REPORTED THAT NONE OF THE TORN TIP WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204991 ANGIOJET XVG CUS CATHETER THROMBECTOMY CATHETER DXE BOSTON SCIENTIFIC 105042-001 182919

    Patients

    Seq Age Sex Outcome Treatment
    1