BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8927409 · Received August 23, 2019

    Report

    Report Number
    2242352-2019-00972
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    July 31, 2019
    Report Date
    August 23, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 11/20/2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THE ENDOLOOP HOLE IN THE END OF THE C-RING (METAL ROD SIDE) WAS OBSERVED TO BE OCCLUDED. A NEEDLE WAS UTILIZED TO TEST THE HOLE. IT WAS UNABLE PASS ALL THE WAY THROUGH DUE TO WHAT APPEARED TO BE PLASTIC. THERE WERE NO OTHER OBSERVED DEFECTS. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE RESULTS OF THE EVALUATION, THE REPORTED FAILURE "MECHANICAL ISSUE" WAS CONFIRMED. THE DHR FOR THE REPORTED FAILURE "MECHANICAL ISSUE" WAS REVIEWED. THE VENDORS CERTIFY THAT ALL THE DEVICE LOTS MANUFACTURED CONFORMS TO ALL THE APPLICABLE PRODUCT SPECIFICATIONS. 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. HOLE IN THE C-RING DID NOT GO ALL THE WAY THROUGH SO THEY COULD NOT USE FOR ENDOLOOP. 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 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. HOLE IN THE C-RING DID NOT GO ALL THE WAY THROUGH SO THEY COULD NOT USE FOR ENDOLOOP. 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
    721254 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25145511

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR