BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 19405983 · Received May 28, 2024

    Report

    Report Number
    2242352-2024-00606
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 6, 2024
    Report Date
    June 24, 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

    TRACKWISE ID#: (B)(4). 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¿. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.

    Additional Manufacturer Narrative · 0

    TW 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. E1 EVENT SITE NAME DUE TO CHARACTER LIMITATIONS LEGACY EMANUEL HOSPITAL AND HLT CTR DEVICE DISCARDED.

    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. RELATED TO TW (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321924 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000380314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown