BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CYTOLOGY BRUSH

    MDR report key: 7314272 · Received March 5, 2018

    Report

    Report Number
    3005099803-2018-00589
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    February 12, 2018
    Report Date
    February 12, 2018
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    UDI-DI
    08714729268628
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 05099803-2018-00612 FOR THE FIRST SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER, 3005099803-2018-00617 FOR THE SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER, AND 3005099803-2018-00589 FOR THE RX CYTOLOGY BRUSH. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS & DELIVERY CATHETER AND AN RX CYTOLOGY BRUSH WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. A SECOND SPYSCOPE DS WAS USED AND THE WORKING CHANNEL SLEEVE PROTRUDED. REPORTEDLY, NO PART OF THE SPYSCOPE DS DEVICES DETACHED. AN RX CYTOLOGY BRUSH WAS ALSO USED DURING THE PROCEDURE AND THE BRUSH WAS DIFFICULT TO EXTEND AND IT WAS ALSO NOTED THAT THE WIRE INSIDE THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH THE SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND THE SAME 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
    157159 RX CYTOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 08714729268628

    Patients

    Seq Age Sex Outcome Treatment
    1