BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 2969511 · Received February 20, 2013

    Report

    Report Number
    3005099803-2013-00925
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K NUMBER IS K112994. INVESTIGATION RESULTS - VISUAL EVALUATION OF THE COMPLAINT DEVICE COULD THE EXIT MARKER TO BE BUNCHED AND LOOSE ON THE CATHETER. THE BALLOON WAS ABLE TO BE INFLATED TO ITS SPECIFIED PRESSURES OF 3, 5 AND 8 ATM. THE COMPLAINT WAS CONFIRMED AND IS CONSISTENT WITH FORCIBLE CATHETER INSERTION OR REMOVAL THROUGH THE SCOPE. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE DEVICE. 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 OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A REMOVAL OF STONES PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2013. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE DEVICE WAS ADVANCED DOWN THE SCOPE. HOWEVER, WHEN THE BALLOON EXITED THE SCOPE, IT WAS NOTED THAT THE BLACK EXIT MARKER WAS PEELED. THE DEVICE WAS REMOVED FOR THE SCOPE AND ANOTHER CRE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A REMOVAL OF STONES PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2013. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE DEVICE WAS ADVANCED DOWN THE SCOPE. HOWEVER, WHEN THE BALLOON EXITED THE SCOPE, IT WAS NOTED THAT THE BLACK EXIT MARKER WAS PEELED. THE DEVICE WAS REMOVED FOR THE SCOPE AND ANOTHER CRE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73035 CRE¿ WIREGUIDED BALLOON DILATOR KNQ BOSTON SCIENTIFIC - CORK M00558680 15623778

    Patients

    Seq Age Sex Outcome Treatment
    1