BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM

    MDR report key: 1904507 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04766
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH THE BRUSH EXTENDED. THE HANDLE WAS ACTUATED, AND IT WAS FOUND THAT THE BRUSH WOULD RETRACT WITH SOME RESISTANCE, BUT THE BRUSH WOULD NOT RETRACT FULLY UNLESS THE SHEATH WAS HELD STRAIGHT. THE WIRE ASSEMBLY WAS REMOVED FROM THE PROXIMAL END OF THE T-FITTING, AND THREE BENDS WERE IDENTIFIED IN THE WIRE. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WAS DEFECTIVE AND WOULD NOT RETRACT; THE COMPLAINT WAS CONFIRMED. SINCE THE DEFECT WAS IDENTIFIED OUTSIDE THE PATIENT PRIOR TO THE PROCEDURE, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    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 ON (B)(6) 2010 THAT AN RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON FEMALE PATIENT IN HER FIFTIES ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THE BRUSH WAS UNPACKED, IT WAS NOTED THAT THE DISTAL TIP OF THE BRUSH WAS BENT AND THE BRUSH COULD NOT BE RETRACTED INTO THE SHEATH. NO DAMAGE TO THE PACKAGING WAS NOTED. 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 "FINE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT AN RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THE BRUSH WAS UNPACKED, IT WAS NOTED THAT THE DISTAL TIP OF THE BRUSH WAS BENT AND THE BRUSH COULD NOT BE RETRACTED INTO THE SHEATH. NO DAMAGE TO THE PACKAGING WAS NOTED. 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 FINE.

    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 13065441

    Patients

    Seq Age Sex Outcome Treatment
    1