BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 2857670 · Received December 5, 2012

    Report

    Report Number
    3005099803-2012-05660
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510K NUMBER IS K112994. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. THEREFORE, A DEVICE EVALUATION HAS NOT BEEN PERFORMED. HOWEVER, THE COMPLAINT WAS DUE TO KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION. 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. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    THE 510K NUMBER IS K112994. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, 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 BALLOON DILATATION CATHETER WAS USED DURING A CHOLEDOCHOLITH REMOVAL PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE CRE WIREGUIDED BILIARY BALLOON WAS INSERTED INTO THE CBD AND INFLATED; HOWEVER, THE PATIENT REPORTED PAIN AND THE INFLATION WAS STOPPED. WHEN THE BALLOON WAS REMOVED, IT WAS NOTED THAT THE PATIENT WAS BLEEDING IN THE LOCATION WHERE THE BALLOON WAS BEING INFLATED. COMPRESSION WAS APPLIED WITH THE BALLOON AND THE BLEEDING ALMOST STOPPED. THROMBIN WAS APPLIED AND EBD TUBE(7FR 9CM) WAS PLACED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT AND THE PATIENT WAS ADMITTED INTO THE INTENSIVE-CARE UNIT (ICU) FOR OBSERVATION WHERE A BLOOD TRANSFUSION WAS PERFORMED. . THERE WAS NO REPORTED MALFUNCTION OF THE BALLOON. THE PATIENT WAS IN THE ICU FOR FOUR DAYS. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE STABLE. ON (B)(4) 2012, RECEIVED EMAIL CONFIRMING THAT THE INFLATION OF THE DEVICE CAUSED THE BLEEDING; HOWEVER THE BALLOON DID NOT BURST OR HAVE ANY HOLES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A CHOLEDOCHOLITH REMOVAL PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE CRE WIRE GUIDED BILIARY BALLOON WAS INSERTED INTO THE CBD AND INFLATED; HOWEVER THE PATIENT REPORTED PAIN AND THE INFLATION WAS STOPPED. WHEN THE BALLOON WAS REMOVED, IT WAS NOTED THAT THE PATIENT WAS BLEEDING IN THE LOCATION WHERE THE BALLOON WAS BEING INFLATED. COMPRESSION WAS APPLIED WITH THE BALLOON AND THE BLEEDING ALMOST STOPPED. THROMBIN WAS APPLIED AND EBD TUBE (7FR 9CM) WAS PLACED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT AND THE PATIENT WAS ADMITTED INTO THE INTENSIVE-CARE UNIT (ICU) FOR OBSERVATION WHERE A BLOOD TRANSFUSION WAS PERFORMED. . THERE WAS NO REPORTED MALFUNCTION OF THE BALLOON. THE PATIENT WAS IN THE ICU FOR FOUR DAYS. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE¿ WIREGUIDED BALLOON DILATOR KNQ BOSTON SCIENTIFIC - CORK M00558710 15487842

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization