BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1505449 · Received September 25, 2009

    Report

    Report Number
    3006262933-2009-01107
    Event Type
    Malfunction
    Date Received
    September 25, 2009
    Date of Event
    September 14, 2009
    Report Date
    September 14, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE VISUAL INSPECTION REVEALED THAT THE BLACK INFLATION VALVE HAD POPPED OUT. BASED ON THE REPORTED COMPLAINT AND THE VISUAL ANALYSIS, THIS IS A CASE OF THE VALVE BACKING OUT OF THE LUER FITTING CAUSING THE BALLOON TO DEFLATE DUE TO A DEFECTIVE VALVE SUBASSEMBLY. THE REPORTED FAILURE "SHORT PORT BTT BLACK INFLATION VALVE DISLODGED" WAS CONFIRMED. (B) (4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SYRINGE WAS INSERTED TO THE SHORT PORT BTT TO INFLATE THE BALLOON. WHEN THE SYRINGE WAS REMOVED, THE BLACK INFLATION VALVE POPPED. AS A RESULT, THE BALLOON WOULD NOT REMAIN INFLATED. THE HARVESTER USED A THREE WAY STOP COCK AND COMPLETED THE PROCEDURE WITH THE SAME BTT SHORT PORT. THE HOSPITAL DID NOT REPORT ANY PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-3000 9053071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA