BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 19405770 · Received May 28, 2024

    Report

    Report Number
    2242352-2024-00611
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 6, 2024
    Report Date
    July 25, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    2242352-06/07/2024-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW ID#(B)(4). 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. E1 EVENT SITE NAME DUE TO CHARACTER RESTRICTIONS LEGACY EMANUEL HOSPITAL AND HLT CTR.

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 05/23/2024. AN INVESTIGATION WAS CONDUCTED ON 06/12/2024. A VISUAL INSPECTION WAS CONDUCTED. THE DEVICE WAS RETURNED INSIDE ITS SEALED PRODUCT PACKAGING. THE C-RING WAS OBSERVED TO BE BENT AT A NORMAL ANGLE. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT C-RING. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "MATERIAL DEFORMATION; C-RING" WAS CONFIRMED. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM. THE LOT # 3000380314 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS A RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE "MATERIAL DEFORMATION; C-RING". CAPA 1039601 WAS INITIATED TO ADDRESS THE REPORTED FAILURE "MATERIAL DEFORMATION; C-RING" AND PRODUCT ¿EVH CANNULA.¿

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 HAD A WIRE WITHIN THE HARVESTING TOOL'S SHEATH THAT IS NORMALLY CURVED NATURE OF THE HARVESTING TOOL, AND THE WIRE WAS STRAIGHT. THIS PREVENTED THE HARVESTING TOOL'S PATHWAY TO BE INSERTED INTO THE CANNULA AND THE DEVICE COULD NOT BE USED. THEY OPENED ANOTHER KIT AND NOTICED THE SAME ISSUE AND THAT THE KIT HAD THE SAME LOT NUMBER. THE TEAM THEN PROCEEDED TO OPEN SEVEN OTHER BOXES WITHOUT BREAKING ANY STERILE SEALS AND COULD TELL THAT THE SAME ISSUE WAS AT HAND WITH ALL OF THE OTHER VH-4000 KITS WITH THIS SPECIFIC LOT NUMBER. A NEW DEVICE WITH A DIFFERENT LOT WAS OPENED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299922 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000380314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown