BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 15499532 · Received September 28, 2022

    Report

    Report Number
    2242352-2022-00811
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    September 1, 2022
    Report Date
    October 6, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). UPDATED SECTIONS: B4, G4, G7, H2, H3, H6, H10. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 09/15/2022. AN INVESTIGATION WAS CONDUCTED ON 09/21/2022. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE HARVESTING DEVICE WAS RETURNED INSIDE THE CANNULA. A MECHANICAL EVALUATION WAS CONDUCTED. THE HARVESTING DEVICE WAS REMOVED FROM THE CANNULA WITH NO PHYSICAL OR VISUAL DIFFICULTIES OBSERVED. A REFERENCE ENDOSCOPE WAS INSERTED INTO THE CANNULA UNTIL IT SNAPPED INTO PLACE. THE HARVESTING DEVICE WAS THEN INSERTED INTO THE CANNULA WITH NO PHYSICAL OR VISUAL DIFFICULTIES OBSERVED. THE C-RING WAS ABLE TO RETRACTED AND EXTENDED WHILE MANIPULATION OF THE TOGGLE ON THE CANNULA. THE HARVESTING JAWS WERE ABLE TO OPEN AND CLOSE WHILE MANIPULATING THE BLUE TOGGLE ON THE HARVESTING DEVICE. BASED ON THE RETURNED CONDITON OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "MECHANICAL PROBLEM-SCOPE" WAS NOT CONFIRMED. THE LOT # 3000254974 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NCMRS , REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. [NCMR # (B)(4) NOTIFICATION WAS RECEIVED FROM GXO THAT (B)(4) UNITS WERE FOUND DAMAGED DURING THE INBOUND INSPECTION FOR MATERIAL # VH-4000 BATCH # 3000254974. GXO NCMR REF#: (B)(4). BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO R ELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT PRIOR TO THE BEGINNING OF THE ENDOSCOPIC VEIN HARVESTING PROCEDURE THE VASOVIEW HEMOPRO 2 HAD AN "OBSTRUCTION IN THE DEVICE." THEY COULD NOT INSERT THE SCOPE INTO THE CANNULA. THEY WERE PUSHING SO HARD, THEY THOUGHT IT WAS GOING TO BREAK THE SCOPE. THEY DID HAVE TO OPEN A NEW KIT TO COMPLETE THE PROCEDURE WITHOUT ANY ISSUES. NO DELAY IN THE PROCEDURE. NO INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615466 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 3000254974 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male