BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLAMP AORTIC CATHETER

    MDR report key: 729226 · Received June 23, 2006

    Report

    Report Number
    2210968-2006-00441
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 26, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    DXC
    PMA / PMN Number
    K962510
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE RETURNED OF THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. 510(K) #K962510.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE BALLOON WOULD NOT MAINTAIN INFLATION. THE SURGEON COMPLETED THE CASE VIA FIBRILLATORY ARREST. THERE WERE NO ADVERSE PT CONSEQUENCES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLAMP AORTIC CATHETER CLAMP, VASCULAR DXC ETHICON, INC. NA MS0206007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN