BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 12806522 · Received November 12, 2021

    Report

    Report Number
    2029046-2021-01958
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    October 8, 2021
    Report Date
    November 12, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835007886
    PMA / PMN Number
    K892265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (B)(4) NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4)HAS FOUR (4) REPORTS: (1) MFR # 2029046-2021-01958 FOR PRODUCT CODE (B)(4) (WEBSTER¿ ELECTROPHYSIOLOGY CATHETER) (2) MFR # 2029046-2021-01959 FOR PRODUCT CODE (B)(4) (WEBSTER¿ ELECTROPHYSIOLOGY CATHETER) (3) MFR # 2029046-2021-01960 FOR PRODUCT CODE (B)(4) (WEBSTER®CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID) (4) MFR # 2029046-2021-01961 FOR PRODUCT CODE (B)(4) (WEBSTER®CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID) LL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELECTROPHYSIOLOGY (EP) STUDY WITH TWO (2) WEBSTER¿ ELECTROPHYSIOLOGY CATHETER & TWO (2) WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND THE PATIENT EXPERIENCED ATRIOVENTRICULAR (AV) HEART BLOCK REQUIRING PERMANENT PACEMAKER IMPLANTATION. DURING AN EP STUDY, THE PATIENT PRESENTED AV BLOCK OF 1 MINUTE. BACK-UP PACING WITH A CATHETER PLACED IN THE RIGHT VENTRICLE (RV) WAS POSSIBLE. AFTER A WAITING PERIOD UNDER PACING, THE PHYSICIAN TESTED IF THE AV CONDUCTION WAS BACK, BUT IT WAS NOT COMPLETELY. SO CONTINUOUS PACING FROM THE RV CATHETER WAS NECESSARY. THE PATIENT UNDERWENT THEN A CORONAROGRAPHY AND A PACING SONDE (TEMPORARY PACEMAKER) WAS IMPLANTED TO ENSURE BACK-UP PACING IN CASE OF AV BLOCK. THERE IS NO FURTHER INFORMATION ABOUT IF PROLONGED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN OPINION IS THAT IT IS NOT A COMPLICATION DUE TO THE PROCEDURE, BUT A PRE-EXISTING PATIENT-RELATED PROBLEM. NO ABLATION OR ABLATION CATHETER WAS IN USE AT ANY TIME. BASED ON THE INFORMATION INITIALLY PROVIDED, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE BASED ON PHYSICIAN¿S OPINION INDICATING THIS WAS A PATIENT RELATED PRE-EXISTING CONDITION. ON (B)(6) 2021, BIOSENSE WEBSTER INC. (BWI) RECEIVED ADDITIONAL INFORMATION INDICATING THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED. THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS UNCHANGED AND THE PATIENT REQUIRED IMPLANTATION OF A PERMANENT CARDIAC RESYNCHRONIZATION THERAPY (CRT) PACEMAKER. BASED ON THE ADDITIONAL INFORMATION WHICH INDICATED THE PATIENT REQUIRED PERMANENT PACEMAKER IMPLANTATION, THIS EVENT WILL BE CONSERVATIVELY REPORTED AS AN ADVERSE EVENT (SERIOUS INJURY) AGAINST THE BWI DEVICES USED DURING THE EP STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701552 WEBSTER¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC F6QA005CT 30614205M 10846835007886

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention BI DIR 7FR DEF CS,D-F,12 PIN.| BI DIR 7FR DEF CS,D-F,12 PIN.| FIX 6F,4P,A,SD,5MM,12PN EEPROM.| SMARTABLATE GENERATOR KIT-WW.