BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 8043340 · Received November 6, 2018

    Report

    Report Number
    2242352-2018-01092
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 6, 2018
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE BTT DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD WERE OBSERVED. A VISUAL INSPECTION WAS CONDUCTED. BLOOD WAS OBSERVED ON THE SILICONE BALLOON, AND BODY OF THE BTT. THE PRODUCT WAS VIEWED UNDER A MICROSCOPE AND A TEAR/CUT WAS OBSERVED NEAR THE CENTER OF THE BALLOON, MIDWAY BETWEEN THE TOP AND BOTTOM. THE OPENING WAS SMOOTH WITH NO REMOVAL OF MATERIAL. NO OTHER VISUAL DEFECTS WERE OBSERVED. AN INFLATION TEST WAS ATTEMPTED, 25CC OF AIR WAS INTRODUCED INTO THE BALLOON VIA SYRINGE. THE BALLOON WOULD NOT INFLATE. THE PRODUCT WAS SUBMERGED IN A WATER BATH. BUBBLES WERE SEEN RAPIDLY RELEASING FROM THE TEAR/CUT DURING THE BUBBLE EMISSION TEST IN PLAIN WATER. BASED ON THE CONDITION OF THE DEVICE AS FOUND, THE REPORTED COMPLAINT FOR THE REPORTED FAILURE MODE "INFLATION ISSUE" WAS CONFIRMED. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED FOR THE SILICONE BALLOON, BTT. ALL THE TEST RESULTS MEET THE SPECIFICATIONS AND RESULTS. THERE WERE NO NON-CONFORMITIES OBSERVED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO. WHEN BTT PORT WAS NEEDED, CLINICIAN ATTEMPTED TO INFLATE RING AND IT WOULD NOT HOLD AIR. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NCMR¿S FOR THE REPORTED LOT NUMBER. THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO. WHEN BTT PORT WAS NEEDED, CLINICIAN ATTEMPTED TO INFLATE RING AND IT WOULD NOT HOLD AIR. 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
    880776 VASO VIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25139135

    Patients

    Seq Age Sex Outcome Treatment
    1