BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 5615112 · Received April 28, 2016

    Report

    Report Number
    2242352-2016-00393
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    March 29, 2016
    Report Date
    March 31, 2016
    Manufacturer
    MAQUET CV
    Product Code
    DXC
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BALLOON AT BTT PORT WAS UNABLE TO BE INFLATED SINCE THE RUBBER PART OF THE PORT WAS DAMAGED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS NOT RETURNING. THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, VASOVIEW 7 XB BALLOON AT BTT PORT WAS UNABLE TO BE INFLATED SINCE THE RUBBER PART OF THE PORT WAS DAMAGED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS NOT RETURNING. PRIOR TO USE ON A PATIENT, IT WAS NOTED THAT THE BALLOON AT BTT PORT WAS UNABLE TO BE INFLATED SINCE THE RUBBER PART OF THE PORT WAS DAMAGED. NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BALLOON AT BTT PORT WAS UNABLE TO BE INFLATED SINCE THE RUBBER PART OF THE PORT WAS DAMAGED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS NOT RETURNING. THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, VASOVIEW 7 XB BALLOON AT BTT PORT WAS UNABLE TO BE INFLATED SINCE THE RUBBER PART OF THE PORT WAS DAMAGED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS NOT RETURNING. PRIOR TO USE ON A PATIENT, IT WAS NOTED THAT THE BALLOON AT BTT PORT WAS UNABLE TO BE INFLATED SINCE THE RUBBER PART OF THE PORT WAS DAMAGED. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272696 VASOVIEW 7 XB CLAMP, VASCULAR DXC MAQUET CV 25119848

    Patients

    Seq Age Sex Outcome Treatment
    1