BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM

    MDR report key: 2013568 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00689
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE BRUSH FULLY EXTENDED, AND THE BRUSH WOULD EXTEND AND RETRACT AS INTENDED WHEN THE HANDLE WAS ACTUATED. THE DEVICE WAS THEN INSERTED INTO A DUODENOSCOPE AND FUNCTIONED WITH NO ISSUES BOTH WHEN THE SCOPE WAS STRAIGHT AND FULLY DEFLECTED. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT OF DIFFICULTY RETRACTING; THE COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, 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 DURING REMOVAL OF A BILE DUCT STONE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE NURSE WAS UNABLE TO RETRACT THE BRUSH INTO THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING REMOVAL OF A BILE DUCT STONE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE NURSE WAS UNABLE TO RETRACT THE BRUSH INTO THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 13902960

    Patients

    Seq Age Sex Outcome Treatment
    1