BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 8916040 · Received August 21, 2019

    Report

    Report Number
    2242352-2019-00964
    Event Type
    Injury
    Date Received
    August 21, 2019
    Date of Event
    July 27, 2019
    Report Date
    August 21, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON (B)(6) 2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE CONICAL TIP WAS OBSERVED TO BE INTACT, NO VISUAL DEFECTS WERE OBSERVED. A MECHANICAL EVALUATION WAS CONDUCTED. THE CONICAL TIP WAS THREADED ONTO A REFERENCE ENDOSCOPE. NO VISUAL OR PHYSICAL DEFECTS WERE OBSERVED IN THE PROCESS. THE CONICAL TIP WAS SECURELY ATTACHED TO THE ENDOSCOPE AFTER MULTIPLE MANIPULATIONS OF THE REFERENCE ENDOSCOPE. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURES "MECHANICAL ISSUE" AND "DETACHMENT OF DEVICE OR DEVICE COMPONENT" WAS NOT CONFIRMED. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO CONICAL TIP CAME OFF IN THE PATIENTS LEG. THEY WERE ABLE TO RETRIEVE IT OUT WITHOUT ISSUE. 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, VASOVIEW HEMOPRO CONICAL TIP CAME OFF IN THE PATIENTS LEG. THEY WERE ABLE TO RETRIEVE IT OUT WITHOUT ISSUE. 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
    709868 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25146897

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention