BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID

    MDR report key: 14438709 · Received May 19, 2022

    Report

    Report Number
    2029046-2022-01054
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    January 11, 2022
    Report Date
    May 18, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835002409
    PMA / PMN Number
    K090898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED IN ACCORDANCE WITH BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THE CATHETER TIP WAS RUBBED OFF EXPOSING INTERNAL COMPONENTS. ADDITIONALLY, THE CUSTOMER PROVIDED PICTURE(S) OF THE COMPLAINT DEVICE TO HELP AID IN THE INVESTIGATION. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, THE CATHETER SHAFT WAS OBSERVED DAMAGED, HOWEVER, INTERNAL PARTS EXPOSURE WAS NOT OBSERVED IN THE PICTURE(S). ALL UNITS ARE INSPECTED PRIOR TO LEAVING THE FACILITY AS THERE ARE FUNCTIONAL TESTS AND INSPECTIONS AT CONTROL POINTS BASED ON THE PROCESS FLOW DIAGRAM (PFD) PER ITS PART NUMBER TO AVOID THIS TYPE OF DAMAGE FROM LEAVING THE FACILITY. THE ISSUE WAS FURTHER INVESTIGATED BY THE MANUFACTURING TEAM REVEALING THAT THE COMPLAINT UNIT PASSED ALL CONTROLS AND INSPECTIONS SUCCESSFULLY ACCORDING TO THE DEVICE HISTORY RECORD. IT WAS ALSO DETERMINED THAT THE COMPLAINT UNIT IS THE ONLY ONE REPORTED DURING A 1-YEAR PERIOD, AND THEREFORE, IT'S CONSIDERED AN ISOLATED CASE WITH MULTIFACTORIAL REASONS THAT MIGHT LEAD TO THIS DEFECT. BASED ON THE INFORMATION AVAILABLE, IT WAS DETERMINED THAT THE DAMAGE IS NOT RELATED TO MANUFACTURING AND OCCURRED AFTER THE DEVICE LEFT THE MANUFACTURING PROCESS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE PRODUCT INVESTIGATION OF THE RECEIVED SAMPLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL)IDENTIFIED THE CATHETER TIP TO BE BROKEN. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AFTER OPENING THE CATHETER IT LOOKS LIKE THE OUTER PORTION IS RUBBED OFF/ AFFECTED. IT WAS DESCRIBED AS THE OUTER BLUE PORTION OF THE CATHETER LOOKED AS IF IT HAD BEEN RUBBING ON SOMETHING AND COMPROMISED THE OUTER LAYER. I DID NOT SEE ANY EXPOSED WIRES. THERE DID NOT APPEAR TO HAVE ANY SHARP EDGES, HOWEVER THE OUTER POTION OF THE CATHETER WAS SHAVED DOWN. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER REPORTED ISSUE WAS ASSESSED AS NOT MDR REPORTABLE SINCE THE ISSUE OCCURRED OUTSIDE THE PATIENT BODY SO THE RISK TO THE PATIENT FOR SERIOUS INJURY IS LOW. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 21-APR-2022, THE BWI PAL REVEALED A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE TIP WAS RUBBED OFF WITH INTERNAL COMPONENTS EXPOSED. THIS WAS ASSESSED AS AN MDR REPORTABLE BROKEN TIP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393620 WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER INC BD710DF282CT 30701190M 10846835002409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BI DIR 7FR DEF CS,D-F,12 PIN