BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA? NASOBILIARY CATHETER

    MDR report key: 3901810 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02367
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K982508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. 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

    A VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE CATHETER ATTACHED TO A CATHETER CONNECTOR AND A NON-BSC FITTING. THE SPECIFICATION FOR THE OVERALL LENGTH OF THE DEVICE IS 250.0CM +/- 4CM; HOWEVER, ONLY APPROXIMATELY 215CM WAS RETURNED FOR ANALYSIS. THE 100A (LIGHT BLUE) PORTION OF THE WORKING LENGTH WAS SEPARATED AT APPROXIMATELY 163CM FROM THE CONNECTOR, AND APPEARED TO HAVE BEEN CUT BY SCISSORS OR A SIMILAR INSTRUMENT. THE RETURNED MEDIAL SECTION OF THE WORKING LENGTH WAS MEASURED TO BE APPROXIMATELY 52CM. ONLY 3CM OF THE 65D (DARK BLUE) REMAINED ON THE MEDIAL PORTION. THE DISTAL PORTION OF THE CATHETER, INCLUDING THE PIGTAIL, WAS SEPARATED AND NOT RETURNED. FURTHER ANALYSIS OF THE DISTAL END OF THE 65D PORTION FOUND THE FRACTURED SURFACE TO BE IRREGULAR AND JAGGED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CATHETER SEPARATED. HOWEVER, THE AVAILABLE INFORMATION FAILS TO INDICATE A DEFINITE OR PROBABLE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NASOBILIARY CATHETER DEVICE WAS USED DURING AN ENDOSCOPIC NASOBILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE NASOBILIARY CATHETER WAS BEING REPLACED. HOWEVER, BEFORE THE CATHETER WAS REMOVED, IT WAS NOTED FLUOROSCOPICALLY THAT THE DISTAL SECTION OF THE DRAINAGE TUBE HAD DETACHED INTO THE PATIENT¿S STOMACH. THE PROXIMAL SECTION WAS REMOVED; HOWEVER, THE DISTAL SECTION LEFT INSIDE THE PATIENT. IT WAS CONFIRMED THAT IT WAS LATER PASSED NATURALLY. NO VISIBLE DAMAGE TO THE COMPLAINT DEVICE OR THE PACKAGING WAS REPORTED. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NASOBILIARY CATHETER DEVICE WAS USED DURING AN ENDOSCOPIC NASOBILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE NASOBILIARY CATHETER WAS BEING REPLACED. HOWEVER, BEFORE THE CATHETER WAS REMOVED, IT WAS NOTED FLUOROSCOPICALLY THAT THE DISTAL SECTION OF THE DRAINAGE TUBE HAD DETACHED INTO THE PATIENT'S STOMACH. THE PROXIMAL SECTION WAS REMOVED; HOWEVER, THE DISTAL SECTION LEFT INSIDE THE PATIENT. IT WAS CONFIRMED THAT IT WAS LATER PASSED NATURALLY. NO VISIBLE DAMAGE TO THE COMPLAINT DEVICE OR THE PACKAGING WAS REPORTED. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380186 FLEXIMA? NASOBILIARY CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00540110

    Patients

    Seq Age Sex Outcome Treatment
    1