BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 3040966 · Received April 8, 2013

    Report

    Report Number
    2210968-2013-03596
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL PACKAGING OF THE DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. UPON EVALUATION, THERE WAS AN UNSEALED AREA APPROXIMATELY 7 - 7.5 AT THE BOTTOM LEFT SIDE. THERE WAS GOOD, FULL AND COMPLETE SEAL TRANSFER IN THIS AREA INDICATING THAT THE PACKAGE WAS FULLY SEALED DURING MANUFACTURING. THE TRAY IS NOT DAMAGED OR WARPED. THERE IS NO INDICATION AS TO HOW OR WHEN THIS DAMAGE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THERMAL ABLATION PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE DEVICE PACKAGE WAS ONLY PARTIALLY SEALED. THE SEAL WAS NOT INTACT ON THE BOTTOM LEFT OF THE PACKAGE. THE SEAL WAS BROKEN IN THE MIDDLE AND NOT AT THE END OF THE PACKAGE. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143333 THERMACHOICE CATHETER,BALLOON,TRANSCERVICAL MNB ETHICON, INC. NA EEMG05

    Patients

    Seq Age Sex Outcome Treatment
    1