BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM

    MDR report key: 947368 · Received November 6, 2007

    Report

    Report Number
    6000050-2007-00141
    Event Type
    Malfunction
    Date Received
    November 6, 2007
    Report Date
    July 9, 2007
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    ESW
    PMA / PMN Number
    K940838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. A DEVICE HISTORY RECORDS REVIEW, PRODUCT EVALUATION, AND COMPLAINT TREND ANALYSIS ARE IN PROGRESS; RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    NOTES: THIS REPORT IS INTENDED TO REPLACE MANUFACTURER REPORT #9681260-2007-0007. THE DATE OF EVENT IS UNKNOWN. IN 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A PROCEDURE TO PLACE AN ULTRAFLEX ESOPHAGEAL STENT WAS PERFORMED (PATIENT AGE, GENDER AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, PRIOR TO PLACING THE STENT, "A DILATATION WAS PERFORMED AT 12MM WITH A [BSC] CRE [WIRE-GUIDED] BALLOON." IN ADDITION, IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS ATTEMPTING TO RELEASE THE STENT, "RESISTANCE WAS FELT AT TWO-THIRDS DEPLOYMENT." AND, "WHEN THE SUTURE WAS PULLED BY FORCE, THE SYSTEM WAS PULLED." AFTER THE "DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY WITH THE SNARE," IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND ULTRAFLEX ESOPHAGEAL STENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL STENT SYSTEM ESW BOSTON SCIENTIFIC IRELAND, LTD. M00514070 9662035

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR