BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8881529 · Received August 10, 2019

    Report

    Report Number
    2242352-2019-00912
    Event Type
    Malfunction
    Date Received
    August 10, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 9, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION: G4,G7, H2. CORRECTED SECTION: H10. INTERNAL COMPLAINT NUMBER: (B)(4). THE BTT WAS RETURNED TO THE FACTORY FOR EVALUATION. A PHOTOGRAPH WAS PROVIDED BY THE ACCOUNT. BUBBLES WERE OBSERVED ON THE BODY OF THE BTT. AN INVESTIGATION WAS CONDUCTED ON 09/19/2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO TEARS OR RIPS OBSERVED ON THE BTT. THERE WAS NO OBSERVED FAILURES WITH THE BTT SHORT PORT. AN INFLATION TEST WAS CONDUCTED. THE BALLOON WAS INFLATED AND SUBMERGED IN PLAIN WATER TO OBSERVE THE PRESENCE OF BUBBLES. THE DEVICE FAILED THE INFLATION TEST, IT BECAME DEFLATED AND BUBBLES WERE OBSERVED UNDER SUBMERSION. BASED ON THE RETURN CONDITION OF THE DEVICE, THE REPORTED FAILURE "LEAK" WAS CONFIRMED. THE DHR, SHOP FLOOR PAPERWORK WAS REVIEWED . THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS. THE DHR SHOP FLOOR PAPERWORK IS ATTACHED TO THE COMPLAINT FOR REVIEW.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). THE DHR FOR THE REPORTED FAILURE "LEAK" WAS REVIEWED. THE VENDORS CERTIFY THAT ALL THE DEVICE LOTS MANUFACTURED CONFORMS TO ALL THE APPLICABLE PRODUCT SPECIFICATIONS. THERE WERE NO NON-CONFORMITIES OBSERVED. THE BTT WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 09/19/2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO TEARS OR RIPS OBSERVED ON THE BTT. THERE WAS NO OBSERVED FAILURES WITH THE BTT SHORT PORT. AN INFLATION TEST WAS CONDUCTED. THE BALLOON WAS INFLATED AND SUBMERGED IN PLAIN WATER TO OBSERVE THE PRESENCE OF BUBBLES. THE DEVICE FAILED THE INFLATION TEST, IT BECAME DEFLATED AND BUBBLES WERE OBSERVED UNDER SUBMERSION. BASED ON THE RETURN CONDITION OF THE DEVICE, THE REPORTED FAILURE "LEAK" WAS CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEWHEMPRO BTT HAVE LEAKING. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEWHEMPRO BTT HAVE LEAKING. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (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, VASOVIEWHEMPRO BTT HAVE LEAKING. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675540 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (OUS) VH-3000 25146288

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR