BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 1970446 · Received January 20, 2011

    Report

    Report Number
    2242352-2010-04072
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THERE WAS A TEAR IN THE SILICON COATING AND LATEX BALLOON, ABOUT 3 CM LONG FROM THE EDGE TOWARD THE CENTER. THE SUTURE CROSSING THE TEAR HAD SHIFTED. THE DEVICE WAS BLOODY. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT "BALLOON RUPTURED" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BTT (BLUNT TIP TROCAR) PORT WAS INSERTED, BUT PULLED OUT DURING DISSECTION. IT WAS REINSERTED AND THIS TIME INFLATED PER IFU (INSTRUCTIONS FOR USE) WITH 10CC OF AIR. DISSECTION CONTINUED ON THE UPPER THIGH WHEN THE BALLOON ON THE BTT RUPTURED. IT WAS REMOVED AND INSPECTED. IT APPEARED ALL OF THE BALLOON MATERIAL WAS INTACT. ANOTHER BTT PORT WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25014426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other