BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX BILIARY

    MDR report key: 3130049 · Received May 24, 2013

    Report

    Report Number
    3005099803-2013-04368
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A VISUAL EVALUATION WAS PERFORMED. THE GUIDE CATHETER WAS FOUND KINKED AND DETACHED FROM THE PULL WIRE. THE PULL WIRE WAS FOUND BENT AND THE PUSH CATHETER WAS KINKED IN SEVERAL LOCATIONS. THE NOTED DAMAGES WERE LIKELY DUE TO PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A REVIEW OF THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) WAS PERFORMED AND NO ANOMALIES WERE NOTED.

    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

    NOTE: THIS REPORT PERTAINS TO TWO COMPLAINT DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2013-03723 PERTAINS TO THE CYTOLOGY BRUSH, AND MANUFACTURER REPORT #3005099803-2013-04368 PERTAINS TO THE STENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX BILIARY STENT AND A RX CYTOLOGY BRUSH WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN DEPLOYING THE STENT INSIDE THE PATIENT, THE GUIDE CATHETER BROKE AND WAS LEFT INSIDE THE STENT. THE BROKEN PORTION OF THE GUIDE CATHETER AND STENT WERE REMOVED FROM THE PATIENT WITH A SNARE. THE RX CYTOLOGY BRUSH COULD NOT BE ADVANCED TO THE TARGET SITE IN THE DISTAL COMMON BILE DUCT DUE TO A STRICTURE. EXCESSIVE FORCE WAS APPLIED TO THE HANDLE OF THE RX CYTOLOGY BRUSH DEVICE, AND THE HANDLE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX BILIARY STENT AND RX CYTOLOGY BRUSH. 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 FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO TWO COMPLAINT DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2013-03723 PERTAINS TO THE CYTOLOGY BRUSH, AND MANUFACTURER REPORT #3005099803-2013-04368 PERTAINS TO THE STENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX BILIARY STENT AND A RX CYTOLOGY BRUSH WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN DEPLOYING THE STENT INSIDE THE PATIENT, THE GUIDE CATHETER BROKE AND WAS LEFT INSIDE THE STENT. THE BROKEN PORTION OF THE GUIDE CATHETER AND STENT WERE REMOVED FROM THE PATIENT WITH A SNARE. THE RX CYTOLOGY BRUSH COULD NOT BE ADVANCED TO THE TARGET SITE IN THE DISTAL COMMON BILE DUCT DUE TO A STRICTURE. EXCESSIVE FORCE WAS APPLIED TO THE HANDLE OF THE RX CYTOLOGY BRUSH DEVICE, AND THE HANDLE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX BILIARY STENT AND RX CYTOLOGY BRUSH. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231597 RX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00545670 15634500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention