BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRE 18-20MM 8CM F/G

    MDR report key: 830236 · Received March 21, 2007

    Report

    Report Number
    6000122-2007-00004
    Event Type
    Injury
    Date Received
    March 21, 2007
    Date of Event
    February 16, 2007
    Report Date
    February 21, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KNQ
    PMA / PMN Number
    k971320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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. THE FEBRUARY 2007, 15-MONTH COMPLAINT TREND REPORT FOR THIS PRODUCT FAMILY, FOR ALL COMPLAINT FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED. NO DATA POINTS EXCEED THE BCS ACTION TRIGGER LIMIT. A SHIPMENT HISTORY WILL BE DONE IDENTIFYING POTENTIAL LOTS SOLD TO THIS CUSTOMER. A DEVICE HISTORY RECORD REVIEW, AS WELL AS A COMPLAINT HISTORY REVIEW, WILL BE COMPLETED; RESULTS OF THESE REVIEWS WILL BE SUBMITTED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    ON FEBRUARY 21, 2007 IT WAS REPORTED TO BSC THAT, DURING AN ESOPHAGOGASTRODUODENOSCOPY (EDG) WITH DILATION, (FEMALE PATIENT, AGE UNKNOWN) WHEN "INFLATING (THE) BALLOON (TECHNICIAN) FELT THAT THE GAGE JUMPED AND THE BALLOON BURST." THIS RESULTED IN A PERFORATED ESOPHAGUS, AS REPORTED IN A RELATED COMPLAINT (SEE MANUFACTURER'S REPORT NO. 6000151-2007-00003 FOR CORRESPONDING REPORT ON THE ALLIANCE INFLATION SYRINGE USED IN THE PROCEDURE). ADDITIONALLY, IT WAS REPORTED THE PHYSICIAN "ENDOSCOPICALLY CLIPPED THE ESOPHAGEAL PERFORATION WITH BSC'S RESOLUTION CLIPS. THEY KEPT THE PATIENT IN THE HOSPITAL TO OBSERVE AND TO SEE IF (THE PATIENT) NEEDED SURGERY. (SHE) DID NOT NEED SURGERY AND THE PATIENT WAS LATER RELEASED TO GO HOME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE 18-20MM 8CM F/G KNQ KNQ BOSTON SCIENTIFIC CORK LTD. M00558380 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R