BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CYTOLOGY BRUSH

    MDR report key: 3130067 · Received May 24, 2013

    Report

    Report Number
    3005099803-2013-03723
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: DIFFICULTY ACCESSING COMMON BILE DUCT. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(6). VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE BRUSH WAS ATTACHED AND RETRACTED UPON RECEIPT. THE WORKING LENGTH (CATHETER AND PULL WIRE) WAS BENT/KINKED IN NUMEROUS LOCATIONS THROUGHOUT. THE HANDLE CANNULA WAS BENT AT THE DISTAL END OF THE THUMB RING AND DETACHED APPROXIMATELY 3.0 CM FROM THE DISTAL END OF THE THUMB RING. FUNCTIONAL EVALUATION FOUND THAT WHEN THE DEVICE WAS INSERTED INTO AN ENDOSCOPE WITH A 2.8 MM CHANNEL, RESISTANCE WAS FELT DUE TO KINKS IN THE WORKING LENGTH. HOWEVER, THE DEVICE WAS ABLE TO BE MANEUVERED THROUGH THE SCOPE WITH EFFORT. THE BRUSH COULD NOT BE EXTENDED DUE TO THE DETACHMENT OF THE HANDLE CANNULA. WHEN A PAIR OF FORCEPS WAS USED TO ASSIST EXTENDING THE BRUSH, THE BRUSH STILL WOULD NOT EXTEND. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT, SINCE ANATOMICAL FACTORS OR MANIPULATION OF THE DEVICE DURING USE COULD CAUSE THE WORKING LENGTH TO KINK/BEND. ONCE THE WORKING LENGTH WAS SIGNIFICANTLY KINKED/BENT, THE BRUSH WOULD BE DIFFICULT TO ADVANCE THROUGH THE ENDOSCOPE AND WOULD NOT EXTEND PROPERLY. CONTINUED EFFORTS TO EXTEND THE BRUSH CAN CAUSE THE HANDLE CANNULA TO BEND AND DETACH FROM THE THUMB RING. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT NUMBER.

    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
    232488 RX CYTOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 15889154

    Patients

    Seq Age Sex Outcome Treatment
    1