BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 1931640 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05230
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    October 1, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. THE BALLOON PORTION OF THE DEVICE WAS RETURNED FOR EVALUATION, WITH ONLY A PORTION OF THE CATHETER REMAINING ATTACHED. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THE BLACK EXIT MARKER ON THE CATHETER TO BE BUNCHED. NO OTHER DEFECTS WERE NOTED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE EVENT THAT THE DEVICE WAS DIFFICULT TO WITHDRAW FROM THE ENDOSCOPE AND WAS CUT IN ORDER TO BE REMOVED. BASED ON THIS INFORMATION, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED LIMIT PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A DILATATION PROCEDURE PERFORMED ON (B)(6), 2010 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE; HOWEVER, DURING WITHDRAWAL, THE DEVICE GOT STUCK IN THE ENDOSCOPE AND WAS CUT IN ORDER TO BE REMOVED. AFTER THE DEVICE WAS REMOVED, THE CATHETER WAS FOUND TO BE KINKED. NO OTHER VISIBLE ISSUES WERE NOTED TO THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; EXIT MARKER BUNCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE(TM) BALLOON DILATATION CATHETER ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558500

    Patients

    Seq Age Sex Outcome Treatment
    1