BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAK BACK II DISPOSABLE PULLBACK DEVICE

    MDR report key: 4081141 · Received August 30, 2014

    Report

    Report Number
    2939520-2014-00073
    Event Type
    Malfunction
    Date Received
    August 30, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 30, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K003938
    Removal / Correction Number
    2939520-8/14/14-001R
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE #2939520-8/14/14-001R. DURING PLANNED MANUFACTURING TRANSFER ACTIVITIES, A ROUTINE REVIEW OF THE DESIGN HISTORY RECORD WAS CONDUCTED. DURING THIS REVIEW, IT WAS DISCOVERED THAT THE TRANSPORTATION VALIDATION DOCUMENTATION COULD NOT BE LOCATED. A TRANSPORTATION VALIDATION WAS CONDUCTED. DURING THE BUBBLE EMISSION PORTION OF THE TEST, (B)(4) PACKAGES TESTED FAILED THE BUBBLE EMISSION TEST. VOLCANO INITIATED A VOLUNTARY RECALL OF ALL LOTS OF TRAK BACK II DISTRIBUTED WITHIN THE PREVIOUS 25 MONTHS. FURTHER INFORMATION REGARDING THIS ACTIVITY WILL BE COMMUNICATED TO FDA VIA ROUTINE COMMUNICATIONS RELATIVE TO THE ABOVE REFERENCED RECALL NOTIFICATION NUMBER.

    Description of Event or Problem · 1

    TRANSPORTATION TESTING PERFORMED FOR THE TRAK BACK II DEVICE RESULTED IN AN 11% FAILURE RATE FOR BUBBLE EMISSION. UPON REVIEW, THE DETERMINATION WAS MADE THAT THE STERILITY OF THE PRODUCT FOLLOWING THE SHIPMENT PROCESS MIGHT BE COMPROMISED. TO DATE, VOLCANO CORPORATION HAS NOT RECEIVED ANY REPORTS FROM CUSTOMERS/USERS REGARDING THIS ISSUE. ADDITIONALLY, THERE ARE NO REPORTED CASES OF PATIENT INJURY OR ADVERSE EVENTS THAT COULD BE POTENTIALLY RELATED TO THIS FAILURE MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530968 TRAK BACK II DISPOSABLE PULLBACK DEVICE PULL BACK DEVICE DQO VOLCANO CORPORATION 91003 VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1