BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 10937936 · Received December 3, 2020

    Report

    Report Number
    2242352-2020-01058
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    November 9, 2020
    Report Date
    November 30, 2020
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). UPDATED SECTIONS: G4, G7, H2, H6, H10. THE LOT #25150926 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 BALLOON OF THE BBT PORT WAS BROKEN AND COULD NOT BE EXPANDED. THE PROCEDURE WAS CONTINUED AS IT WAS, BUT SINCE THE PNEUMOPERITONEUM PRESSURE COULD NOT BE SECURED, THE CONTINUATION OF THE PROCEDURE (ERAH) WAS ABANDONED AND THE RADIAL ARTERY WAS COLLECTED OPENLY. THERE WAS NO EFFECT ON THE PATIENT.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID # (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. DEVICE DISCARDED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 BALLOON OF THE BBT PORT WAS BROKEN AND COULD NOT BE EXPANDED. THE PROCEDURE WAS CONTINUED AS IT WAS, BUT SINCE THE PNEUMOPERITONEUM PRESSURE COULD NOT BE SECURED, THE CONTINUATION OF THE PROCEDURE (ERAH) WAS ABANDONED AND THE RADIAL ARTERY WAS COLLECTED OPENLY. THERE WAS NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403225 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 25150926 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention