BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CYTOLOGY BRUSH

    MDR report key: 3790196 · Received May 5, 2014

    Report

    Report Number
    3005099803-2014-01887
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: A VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CATHETER AND THE DRIVE WIRE WERE SEVERELY KINKED THROUGHOUT. ALSO, THE HANDLE WAS BENT APPROXIMATELY 2.7 CM FROM THE ORANGE THUMB RING. THE BLUE CAP WAS RECEIVED COMPLETELY LOOSENED AND PULLED OUT OF THE T-FITTING. THE CATHETER WAS NOT DETACHED. FUNCTIONAL INSPECTION WAS PERFORMED, AND THE DRIVE WIRE DID NOT MOVE WHEN THE HANDLE WAS ACTUATED. THE HANDLE ASSEMBLY WAS THEN DISASSEMBLED, AND IT WAS FOUND THAT THE DRIVE WIRE HAD BROKEN NEAR WHERE IT JOINS WITH THE HYPOTUBE. THE COMPLAINT THAT THE WORKING LENGTH DETACHED WAS NOT CONFIRMED; HOWEVER, THE INVESTIGATION CONFIRMED THE COMPLAINT OF WORKING LENGTH BENT. MOST LIKELY, THE WORKING LENGTH KINKED DURING INSERTION OF THE BRUSH INTO THE ENDOSCOPE. CONTINUED EFFORTS TO EXTEND THE BRUSH AGAINST THESE KINKS WOULD CAUSE THE HANDLE TO BEND AND WOULD EVENTUALLY BREAK THE PULL WIRE. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THE IDENTIFIED FAILURES IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF WORKING LENGTH DETACHED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH HISTOLOGICAL DIAGNOSIS PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH BENT THEN DETACHED BEFORE THE TIP OF THE BRUSH EXIT AT THE DISTAL END OF THE SHEATH, THUS, MAKING THE PHYSICIAN UNABLE TO USE THE BRUSH IN PERFORMING CYTOLOGY. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH HISTOLOGICAL DIAGNOSIS PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH BENT THEN DETACHED BEFORE THE TIP OF THE BRUSH EXIT AT THE DISTAL END OF THE SHEATH, THUS, MAKING THE PHYSICIAN UNABLE TO USE THE BRUSH IN PERFORMING CYTOLOGY. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267620 RX CYTOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 16779900

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR