BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATION CATHETER

    MDR report key: 1230997 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05546
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE BALLOON INFLATION, DEFLATION AND ADVANCEMENT DIFFICULTIES WERE ENCOUNTERED. A CRE WG 15-18MM/180CM/5.5 F/G BALLOON CATHETER HAD BEEN SELECTED TO TREAT AN UNSPECIFIED ESOPHAGEAL STRICTURE. THE BALLOON CATHETER WAS REMOVED FROM ITS PACKAGING, ATTACHED TO AN ALLIANCE INFLATION DEVICE AND HANDED TO THE PHYSICIAN. NO VACUUM WAS APPLIED TO THE DEVICE. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE DEVICE THROUGH THE SCOPE AS THE BALLOON APPEARED PARTIALLY INFLATED. ATTEMPTS TO DEFLATE THE BALLOON WERE UNSUCCESSFUL. THE DEVICE DID NOT CONTACT THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATION CATHETER KNQ BOSTON SCIENTIFIC M00558430

    Patients

    Seq Age Sex Outcome Treatment
    1