BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2031959 · Received March 16, 2011

    Report

    Report Number
    2242352-2010-04164
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    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: A VISUAL INSPECTION REVEALED THE SHORT PORT HAD NO NON-CONFORMITIES BUT WOULD NOT INFLATE WHEN INFLATED WITH 25 CC OF AIR. PART OF THE PROXIMAL SUTURE APPEARED SHIFTED. THE DEVICE WAS BLOODY. BASED UPON THE REC'D CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "BLUNT TIP TROCAR (BTT) RUPTURED UPON INFLATION" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BALLOON BLUNT TIP TROCAR (BTT) RUPTURED UPON INFLATION. THE PROCEDURE WAS COMPLETED BY OPENING THE LEG, BUT DUE TO ANOTHER PRODUCT MALFUNCTION REPORTED IN MFR REPORT # 2242352-2010-03770, WHEN THE HARVESTER ATTEMPTED TO USE A NEW VASOVIEW HEMOPRO WITH THE VASOVIEW HEMOPRO POWER SUPPLY, THE UNIT DID NOT DELIVER ENERGY, SO THE PROCEDURE WAS CONVERTED TO OPEN LEG. THERE WERE NO OTHER PT EFFECTS REPORTED. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM SHORT PORT BTT GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25020807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other