BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 16291316 · Received February 3, 2023

    Report

    Report Number
    2029046-2023-00216
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 10, 2023
    Report Date
    February 26, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835002997
    PMA / PMN Number
    P990025/S12
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/WOLFF-PARKINSON-WHITE SYNDROME (WPW) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE CATHETER TIP WAS BROKEN. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT DURING A PROCEDURE WHEN TAKING THE CATHETER OUT OF ITS PACKAGING THE CATHETER LOOKED DAMAGED. THEY REPORTED THAT A "CHUNK OF THE CATHETER WAS MISSING AROUND THE TIP" AND A "WIRE WAS STICKING OUT OF THE END". TO TROUBLESHOOT THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS CONTINUED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. BWI CONDUCTED A VISUAL INSPECTION. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED NO BIOLOGICAL MATERIAL WAS FOUND, AND NO PHYSICAL DAMAGE WAS OBSERVED. ONLY AN ANCHOR WINDOW BETWEEN ELECTRODES 2 AND 3 WHICH IS PART OF THE DESIGN OF THIS DEVICE. POLYURETHANE IS APPLIED ON THE ANCHOR WINDOW. THE EVENT DESCRIBED ABOUT THE BROKEN TIP, COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY ISSUES. ALTHOUGH NO ISSUES WERE IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. AS PART OF BWI¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 31-JAN-2023, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/WOLFF-PARKINSON-WHITE SYNDROME (WPW) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE CATHETER TIP WAS BROKEN. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT DURING A PROCEDURE WHEN TAKING THE CATHETER OUT OF ITS PACKAGING THE CATHETER LOOKED DAMAGED. THEY REPORTED THAT A "CHUNK OF THE CATHETER WAS MISSING AROUND THE TIP" AND A "WIRE WAS STICKING OUT OF THE END". TO TROUBLESHOOT THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS CONTINUED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER, DAMAGE WAS NOTICED SO NOT INSERTED. THE ISSUE WAS FOUND BETWEEN ELECTRODES 2 AND 3. CATHETER WAS NOT PRE-SHAPED. SHEATH USED WAS A PRELUDE PSI, MERIT 7FR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286545 EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC BN7TCDF4L 30877744M 10846835002997

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PRELUDE PSI, MERIT 7FR SHEATH.