BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 8935662 · Received August 27, 2019

    Report

    Report Number
    2242352-2019-00976
    Event Type
    Injury
    Date Received
    August 27, 2019
    Date of Event
    July 17, 2019
    Report Date
    November 14, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION B1, B2, H1, H3 - OTHER PROVIDE CODE CHANGED TO DEVICE DISCARDED, H6 - EVALUATION METHOD CODE DEVICE NOT RETURNED CHANGED TO DEVICE DISCARDED. (B)(4). H3 OTHER TEXT: DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2 C-RING BROKE INSIDE PATIENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE # (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 NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2 C-RING BROKE. 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
    731603 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 25144436

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention