BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB, OUS

    MDR report key: 19405586 · Received May 28, 2024

    Report

    Report Number
    2242352-2024-00613
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 3, 2024
    Report Date
    July 30, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE
    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.

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 06/06/2024. A PHOTOGRAPH WAS PROVIDED BY THE ACCOUNT. A PHOTOGRAPHIC EVALUATION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. PRODUCT INFORMATION WAS OBSERVED. THE BASE OF THE BTT WAS OBSERVED TO BE CHIPPED AND BROKEN OFF, WITH A PIECE OF THE BASE OF BTT DETACHED. THE DETACHED PIECE OF THE BTT WAS NOT OBSERVED IN THE PHOTOGRAPH. AN INVESTIGATION WAS CONDUCTED ON 06/19/2024. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE BASE OF THE BTT WAS OBSERVED TO BE BROKEN, WITH A PIECE OF THE BASE OF BTT DETACHED. THE DETACHED PIECE OF THE BTT WAS NOT RETURNED FOR EVALUATION. THE BTT WAS ABLE TO BE INFLATED. NO VISUAL DEFECTS WERE OBSERVED ON THE SILICONE BTT. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE PHOTOGRAPHIC EVALUATION AND EVALUATION RESULTS, THE REPORTED FAILURE "BREAK" WAS CONFIRMED. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS. THE LOT # 3000348178 HISTORY RECORD REVIEW WAS COMPLETED. THERE WAS A NCMR, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR (OUS) BTT WAS FOUND BROKEN AFTER WITHDRAW FROM WOUND. THE SAME DEVICE WAS USED TO COMPLETE THE CASE AS IT WAS DISCOVERED AFTER REMOVAL OF THE BTT AND THE PROCEDURE WAS ALREADY COMPLETED. NO DELAY. NO HARM. PER PHOTO PROVIDED BY THE COMPLAINANT, IT IS OBSERVED THAT A PIECE FROM THE BTT RIM IS CHIPPED, AND BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688701 VASOVIEW 7 XB, OUS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-3200-W 3000348178

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown