BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE? WIREGUIDED

    MDR report key: 3150248 · Received June 6, 2013

    Report

    Report Number
    3005099803-2013-04323
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. (B)(4) FOR THE REPORTED EVENT OF EXIT MARKER BUNCHED. THE 510K NUMBER IS K112994. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CATHETER BALLOON WAS CUT SEGREGATING THE BALLOON AND EXIT MARKER PORTION OF THE CATHETER. THE CATHETER WAS INSPECTED FOR COSMETIC DEFECTS AND NO DEFECTS WERE NOTED. THE BALLOON WAS FOUND RELAXED AND DEFLATED WITH NO WINGTOOL. THE BALLOON WAS INSPECTED AND NO DAMAGE WAS NOTED. THE EXIT MARKER ¿BLACK SHEET PART ON THE CATHETER¿ WAS FOUND TO BE BUNCHED AT BOTH THE DISTAL AND PROXIMAL END AND LOOSE ALONG THE SECTION OF THE CUT CATHETER. THE REPORTED DEFECT OF EXIT MARKER LOOSE DETACHED WAS CONFIRMED. THE ACCORDION APPEARANCE OF THE DAMAGE TO THE EXIT MARKER IS CONSISTENT WITH FORCIBLE CATHETER WITHDRAWAL. IT IS LIKELY THAT ON REMOVAL OF THE DEVICE THE EXIT MARKER WAS CAUGHT IN THE SCOPE AND IN ADDITION TO THE FORCES USED TO INSERT THE CATHETER, THIS COMPLAINT WILL HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT ASSIGNED AS THE COMPLAINT WAS MOST LIKELY CAUSED BY PROCEDURAL/ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED PERFORMANCE OF THE DEVICE. THE MES DHR REVIEW WAS PERFORMED AND THERE WAS NO NON-CONFORMANCE RAISED FOR THE LOT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE; HOWEVER, DURING WITHDRAWAL, THE BLACK EXIT MARKER ON THE CATHETER BUNCHED AND STOPPED THE CATHETER FROM ENTERING THE WORKING CHANNEL OF THE SCOPE. 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 STABLE. PICTURES OF THE COMPLAINT DEVICE WERE RECEIVED AND SHOW THAT THE EXIT MARKER IS BUNCHED. NO OTHER DAMAGE WAS NOTED IN THE PHOTOGRAPHS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE; HOWEVER, DURING WITHDRAWAL, THE BLACK EXIT MARKER ON THE CATHETER BUNCHED AND STOPPED THE CATHETER FROM ENTERING THE WORKING CHANNEL OF THE SCOPE. 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 STABLE. PICTURES OF THE COMPLAINT DEVICE WERE RECEIVED AND SHOW THAT THE EXIT MARKER IS BUNCHED. NO OTHER DAMAGE WAS NOTED IN THE PHOTOGRAPHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250487 CRE? WIREGUIDED BALLOON DILATOR KNQ BOSTON SCIENTIFIC - CORK M00558710 0015816059

    Patients

    Seq Age Sex Outcome Treatment
    1