BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R.E. BALLOON DILATATION CATHETER

    MDR report key: 1455076 · Received June 2, 2009

    Report

    Report Number
    3005099803-2009-02656
    Event Type
    Malfunction
    Date Received
    June 2, 2009
    Date of Event
    February 27, 2009
    Report Date
    May 5, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE PROTECTIVE SLEEVE WAS MISSING FROM THE DEVICE. THE STOPCOCK WAS RETURNED WITH THE UNIT. THE PROFILE OF THE BALLOON WAS RELAXED AND THE BALLOON WAS TORN LONGITUDINALLY. THIS FAILURE OCCURS DUE TO CONTACT WITH A SHARP EXTERIOR SOURCE SUCH AS A CALCIFIED LESION, SURGICAL STAPLES OR SUTURES, ETC; OR AS A RESULT OF DAMAGE TO THE BALLOON DURING INSERTION THROUGH THE SCOPE. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS OPERATIONAL CONTEXT. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO ANOMALIES WERE IDENTIFIED RELATED TO THIS COMPLAINT. A LOT HISTORY REVIEW WAS PERFORMED WHICH DID NOT REVEAL ANY OTHER COMPLAINTS ASSOCIATED WITH THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS INITIAL REPORTED TO BOSTON SCIENTIFIC CORP THAT THE EXTRACTOR RX RETRIEVAL BALLOON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE BALLOON HAD A PIN-HOLE LEAK AND WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR RX RETRIEVAL BALLOON. THERE WAS NO REPORT OF PT COMPLICATIONS OR INJURY DUE TO THIS EVENT. POST PROCEDURE, THE PT WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; LONGITUDINAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R.E. BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORK LTD M00558370 0011870735

    Patients

    Seq Age Sex Outcome Treatment
    1