BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7XB SHORT PORT BTT

    MDR report key: 1590461 · Received January 27, 2010

    Report

    Report Number
    2648729-2009-00337
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    December 10, 2009
    Report Date
    December 14, 2009
    Manufacturer
    MAQUET PUERTO RICO, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VH-3200 SHORT PORT BTT BLACK INFLATION VALVE POPPED OUT. THE "PER" STATED "DURING A NORMAL ROUTINE USE OF THE VASOVIEW 7, THE BLACK BIT OF PLASTIC OF THE SYRINGE GAS INLET HAD POPPED OUT FROM THE CONNECTOR. THUS, THE GAS SYRINGE COULD NOT BE INSERTED INTO THE CONNECTOR. SINCE THEY DID NOT KNOW AN IMMEDIATE SOLUTION OF SOLVING THE PROBLEM, THEY HAD TO OPEN A SET OF INSERTION KIT INSTEAD OF OPENING ANOTHER A WHOLE SET OF VASOVIEW 7. THE NEW BTT WORKS FINE AND THE OPERATION DID NOT ENCOUNTERED FURTHER PROBLEMS." THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT ACCESSORY KIT. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS RETURNING. THE MQT/(B)(4) REPRESENTATIVE FOLLOWED UP UPON RECEIPT OF MORE INFORMATION: "ONE SURGEON SAID THE BTT SYRINGE PORT WAS WORKING FINE WHEN AT ATMOSPHERIC PRESSURE (I.E. NO PRESSURE APPLIED ON THE INFLATED PART OF BTT). WHEN HE INSERTED THE BTT AT THE INCISION SITE, AIR LEAKAGE HAPPENED AT THE SYRINGE PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7XB SHORT PORT BTT SHORT PORT BTT GEI MAQUET PUERTO RICO, LLC VH-3200 9091871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA