BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XB DISSECTION TIP

    MDR report key: 1821473 · Received August 24, 2010

    Report

    Report Number
    2242352-2010-02582
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE CONICAL TIP ON THE VASOVIEW 7 XB DISSECTION TIP CRACKED ALLOWING BLOOD TO ENTER IT AND DISRUPTING THE FIELD OF VISION AND DELAYING COMPLETION OF CASE. THE HARVESTER WAS ABLE TO CLEAN OUT THE TIP WITH A SMALL QTIP AND FINISH. THE CASE WAS DELAYED FOR 20 MINS TRYING TO CLEAN. THE HARVESTER HAD TO STOP WORKING ON THE LOWER LEG TEMPORARILY, COMPLETE THE THIGH BRANCH BISECTION, THEN TURN AROUND AGAIN TO RE-ATTEMPT TO DISSECT OUT THE LOWER LEG. BY THAT TIME THE AREA OF BLEEDING HAD SLOWED DOWN SO HE DID NOT GET BLOOD IN THE CONICAL TIP AGAIN. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XB DISSECTION TIP DISSECTION TIP GEI MAQUET CARDIOVASCULAR, LLC VH-3200 25011038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other