BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3866468 · Received April 23, 2014

    Report

    Report Number
    2242352-2014-00468
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DID NOT IDENTIFY ANY NON­ CONFORMITIES. THE BTT BALLOON WAS INFLATED WITH 25 CC OF AIR THROUGH THE BALLOON INFLATION PORT AND SUBMERGED I WATER; THERE WERE BUBBLES OBSERVED OUT OF THE SUTURE LINE PART OF THE SILICONE. THE BTT WAS INSPECTED UNDER A MICROSCOPE; THE SILICONE BALLOON WAS CRACKED (RUPTURE) IN THE SUTURE LINE PART. WHILE WE ARE UNABLE TO CONCLUSIVELY DETERMINE A ROOT CAUSE, EACH BTT UNDERGOES A FULL INFLATION AND DEFLATION INSPECTION PRIOR DISTRIBUTION. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON­ CONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL CORRECTIVE ACTION (WY-2013-94) ISSUED FOR THIS FAILURE MODE. INTERNAL COMPLAINT NUMBER - CATSWEB# (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BALLOON ON THE SHORT PORT OF THE VASO VLEW HEMOPRO DID NOT BLOW UP WHEN TRYING TO INSERT THE SYRINGE. THE CASE WAS COMPLETED BY HOLDING THE SHORT PORT IN PLACE. THE HOSPITAL DID NOT REPORT AN PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244789 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25093185

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR