BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3560759 · Received November 5, 2013

    Report

    Report Number
    2242352-2013-01511
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Date of Event
    October 14, 2013
    Report Date
    October 14, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DID NOT IDENTIFY ANY NON-CONFORMITIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE BTT SHORT PORT BALLOON WAS INFLATED WITH 25 CC OF AIR THROUGH THE BALLOON INFLATION PORT AND SUBMERGE IN WATER; AIR WAS LEAKING FROM THE BALLOON AND FORMING BUBBLES IN THE WATER. THERE WAS A PIN HOLE IN THE BALLOON. WE ARE UNABLE TO CONCLUSIVELY DETERMINE WHERE OR WHEN THE PIN HOLE OCCURRED; HOWEVER, EACH BTT SHORT PORT GOES THROUGH A FULL INFLATION AND DEFLATION INSPECTION PRIOR TO DISTRIBUTION. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING THE HEMOPRO DEVICE, A HOLE WAS OBSERVED IN THE BTT SHORT PORT. THE BTT SHORT PORT WAS INSERTED INTO THE PATIENT'S LEG AND, WHILE ATTEMPTING TO INFLATE THE BALLOON, A HOLE WAS FOUND WHICH WOULD NOT ALLOW THE BALLOON TO INFLATE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570157 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25084240

    Patients

    Seq Age Sex Outcome Treatment
    1