BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 2803278 · Received October 24, 2012

    Report

    Report Number
    3005099803-2012-04932
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 1, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K110833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE DEVICE REVEALED THAT THE EXIT MARKER WAS ACCORDIONED, BUT STILL ATTACHED TO THE DEVICE. THE CATHETER OF THE DEVICE HAD BEEN CUT BY THE CUSTOMER, THEREFORE FUNCTIONAL ANALYSIS WAS NOT POSSIBLE. NO OTHER DAMAGE WAS NOTED TO THE BALLOON PORTION OF THE DEVICE. THE COMPLAINT THAT THE EXIT MARKER ACCORDIONED WAS CONFIRMED. THIS FAILURE CAN OCCUR DUE TO FORCIBLE CATHETER WITHDRAWAL THROUGH THE ENDOSCOPE OR TORTUOUS ANATOMY. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A CRE WIREGUIDED BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE DILATATION PROCEDURE WAS COMPLETED WITH THIS DEVICE SUCCESSFULLY. HOWEVER, WHEN THE BALLOON WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SCOPE, RESISTANCE WAS MET. THEREFORE, THE DEVICE AND ENDOSCOPE WERE REMOVED TOGETHER. THE BALLOON WAS EXAMINED AND IT WAS NOTED THAT THE BLACK EXIT MARKER WAS ACCORDIONED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A CRE WIREGUIDED BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE DILATATION PROCEDURE WAS COMPLETED WITH THIS DEVICE SUCCESSFULLY. HOWEVER, WHEN THE BALLOON WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SCOPE, RESISTANCE WAS MET. THEREFORE, THE DEVICE AND ENDOSCOPE WERE REMOVED TOGETHER. THE BALLOON WAS EXAMINED AND IT WAS NOTED THAT THE BLACK EXIT MARKER WAS ACCORDIONED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE¿ WIREGUIDED ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558490 15310155

    Patients

    Seq Age Sex Outcome Treatment
    1