BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON CATHETER

    MDR report key: 1190814 · Received September 24, 2008

    Report

    Report Number
    3005099803-2008-04815
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE BALLOON WAS TORN LONGITUDINALLY. THE BALLOON PROFILE WAS RELAXED. NO STOPCOCK WAS RETURNED AND THERE WAS NO PROTECTIVE SLEEVE PRESENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO ISSUES WERE NOTED. THIS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT WAS DETERMINED TO BE OPERATIONAL CONTEXT AS IT IS MOST PROBABLE THE BALLOON BURST OCCURRED DUE TO CONTACT WITH A SHARP EXTERIOR SOURCE SUCH AS A CALCIFIED LESION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL DILATION PROCEDURE, THE BALLOON RUPTURED. A CRE 10-12 MM 8 CM F/G BALLOON CATHETER HAS BEEN ADVANCED TO AN UNSPECIFIED ESOPHAGEAL STRICTURE. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON "STEP BY STEP". THE BALLOON RUPTURED AT 8 ATMOSPHERES. "THERE WERE NO FOREIGN MATERIAL THAT COULD CAUSE THE TROUBLE." THE PROCEDURE WAS ABORTED. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON CATHETER KNQ BOSTON SCIENTIFIC M00558350 11870960

    Patients

    Seq Age Sex Outcome Treatment
    1