BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CYTOLOGY BRUSH

    MDR report key: 3033506 · Received April 3, 2013

    Report

    Report Number
    3005099803-2013-02347
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: DIFFICULTY RETRACTING BRUSH. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE BRUSH WAS NOT PRESENT UPON RECEIPT AND THE DISTAL TIP OF THE CATHETER WAS CUT AND THE DISTAL BLUE TIP WAS MISSING. IN ADDITION, VISUAL EVALUATION FOUND THAT THE WORKING LENGTH OF THE DEVICE WAS KINKED IN SEVERAL LOCATIONS, THE ORANGE THUMB RING WAS DETACHED AND NOT RETURNED, AND THE HANDLE CANNULA WAS BENT. FUNCTIONAL EVALUATION FOUND THAT WHEN THE HANDLE CANNULA WAS ACTUATED, IT WAS VERY HARD TO MOVE THE BRUSH WIRE. THE HANDLE WAS DISASSEMBLED AND IT WAS FOUND THAT THE BRUSH WIRE WAS SEVERELY KINKED AT THE DISTAL END OF THE HANDLE CANNULA. THE DEVICE WAS DIFFICULT TO INSERT INTO A DUODENOSCOPE WITH A 2.8 MM WORKING CHANNEL. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT, SINCE INSERTING TOO MUCH OF THE WORKING LENGTH INTO THE SCOPE AT ONE TIME COULD HAVE CAUSED KINKS. ONCE THE WORKING LENGTH BECAME KINKED, IT WOULD NOT ALLOW THE BRUSH TO EXTEND AND RETRACT FREELY. CONTINUED EFFORTS TO ACTUATE THE DEVICE LIKELY CAUSED THE HANDLE CANNULA TO BEND/BREAK. THE DEVICE TIP AND BRUSH WERE REMOVED BY THE CUSTOMER TO OBTAIN THE SAMPLE. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. (MFR. REPORTS # 3005099803-2013-02346 AND # 3005099803-2013-02347). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RX CYTOLOGY BRUSH DEVICES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE FIRST RX CYTOLOGY BRUSH (MFR. REPORT # 3005099803-2013-02346) DOWN THE SCOPE. IN ADDITION, WHILE ATTEMPTING TO EXTEND THE BRUSH, THE THUMB RING BROKE OFF THE HANDLE AND THE HANDLE WIRE BENT. DUE TO THE BENT HANDLE WIRE, THERE WAS DIFFICULTY MOVING THE BRUSH IN AND OUT OF THE SHEATH. A SECOND RX CYTOLOGY BRUSH (SUBJECT OF THIS REPORT) WAS THEN USED. HOWEVER, THERE WAS ALSO DIFFICULTY ADVANCING THE DEVICE THROUGH THE SCOPE. WHILE TRYING TO DEPLOY THE BRUSH, THE THUMB RING BROKE OFF OF THE HANDLE AND THE HANDLE WIRE BENT, MAKING IT DIFFICULT TO MOVE THE BRUSH IN AND OUT OF THE SHEATH. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THESE TWO RX CYTOLOGY BRUSHES. 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 ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. (MFR. REPORTS # 3005099803-2013-02346 AND # 3005099803-2013-02347). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RX CYTOLOGY BRUSH DEVICES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE FIRST RX CYTOLOGY BRUSH (MFR. REPORT # 3005099803-2013-02346) DOWN THE SCOPE. IN ADDITION, WHILE ATTEMPTING TO EXTEND THE BRUSH, THE THUMB RING BROKE OFF THE HANDLE AND THE HANDLE WIRE BENT. DUE TO THE BENT HANDLE WIRE, THERE WAS DIFFICULTY MOVING THE BRUSH IN AND OUT OF THE SHEATH. A SECOND RX CYTOLOGY BRUSH (SUBJECT OF THIS REPORT) WAS THEN USED. HOWEVER, THERE WAS ALSO DIFFICULTY ADVANCING THE DEVICE THROUGH THE SCOPE. WHILE TRYING TO DEPLOY THE BRUSH, THE THUMB RING BROKE OFF OF THE HANDLE AND THE HANDLE WIRE BENT, MAKING IT DIFFICULT TO MOVE THE BRUSH IN AND OUT OF THE SHEATH. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THESE TWO RX CYTOLOGY BRUSHES. 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
    135755 RX CYTOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 15757832

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR