BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEBSTER CORONARY SINUS (CS) CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 19472509 · Received June 5, 2024

    Report

    Report Number
    2029046-2024-01839
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 9, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835009989
    PMA / PMN Number
    K080425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED A WEBSTER CORONARY SINUS (CS) CATHETER WITH AUTO ID TECHNOLOGY AND AT THE END OF THE CASE, THE SMALL FEMORAL SHEATH BROKE IN 2 PIECES. THE CS CATHETER WAS REMOVED WITH NO ISSUE AS IT CAME OUT FREELY. IT WAS NOTED THAT ON THE CS ITSELF, THERE WAS A SMALL NICK ALONG THE CATHETER (MINISCULE TRIANGLE CUT). THE PHYSICIAN IS NOT 100% SURE IF THE CATHETER BROKE INSIDE THE PATIENT AND BELIEVED THAT IT MAY HAVE HAPPENED WHEN PULLING BACK THROUGH THE BROKEN FEMORAL SHEATH. PART FROM SHEATH WAS REMOVED WITH NO PROBLEM POST PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED A GREENISH-WHITE MATERIAL IN THE BASE OF THE CONNECTOR PINS. NO OTHER DAMAGE OR ANOMALIES WERE FOUND. NO BROKEN CONDITION WAS DETECTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31278909M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE BROKEN ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED DURING THE PRODUCT ANALYSIS. OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE CORROSION WAS NOT RELATED TO THE REPORTED EVENT AND THE POTENTIAL CAUSE COULD NOT BE DETERMINED. AS PART OF BIOSENSE WEBSTER¿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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED A WEBSTER CORONARY SINUS (CS) CATHETER WITH AUTO ID TECHNOLOGY AND AT THE END OF THE CASE, THE SMALL FEMORAL SHEATH BROKE IN 2 PIECES. THE CS CATHETER WAS REMOVED WITH NO ISSUE AS IT CAME OUT FREELY. IT WAS NOTED THAT ON THE CS ITSELF, THERE WAS A SMALL NICK ALONG THE CATHETER (MINISCULE TRIANGLE CUT). THE PHYSICIAN IS NOT 100% SURE IF THE CATHETER BROKE INSIDE THE PATIENT AND BELIEVED THAT IT MAY HAVE HAPPENED WHEN PULLING BACK THROUGH THE BROKEN FEMORAL SHEATH. PART FROM SHEATH WAS REMOVED WITH NO PROBLEM POST PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822777 WEBSTER CORONARY SINUS (CS) CATHETER WITH AUTO ID TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31278909M 10846835009989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AVANTI+ INTRODUCER 7F CORDIS SHEATH