BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15408207 · Received September 13, 2022

    Report

    Report Number
    2029046-2022-02208
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    August 17, 2022
    Report Date
    October 26, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835002423
    PMA / PMN Number
    K090898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4). ON 13-SEP-2022 IT WAS DISCOVERED THAT THE DEVICE WAS RECEIVED ON 30-AUG-2022 AND THE INFORMATION WAS IADVERTENTLY OMITTED FROM THE 3500A INITIAL. AS SUCH THE FOLLOWING FIELDS HAVE BEEN PROCESSED: -H3. REASON FOR NON- EVALUATION FROM DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN TO NO -H3. REASON FOR NON- EVALUATION FROM BLANK TO OTHER -H10. ADDITIONAL MANUFACTURER NARRATIVE SHOULD HAVE INCLUDED: THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 30-AUG-2022. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IN ADDITION, DURING AN INTERNAL REVIEW ON 14-SEP-2022, A CORRECTION WAS NOTED TO THE 3500A INITIAL AS WE REPORTED AS A CONCOMITANT PRODUCT ¿REPROCESSED 6FR CS, D, 10 POLE¿; HOWEVER, ON 06-SEP-2022, CLARIFICATION HAD BEEN RECEIVED CORRECTING THIS DEVICE TO ¿REPROCESSED 6FR CS, F, 10 POLE¿. THEREFORE, UPDATED THE ¿D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES¿ FIELD.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS COMPLETED ON 28-SEP-2022. IT WAS REPORTED THAT A 69-YEAR-OLD MALE PATIENT (110 KGS) UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB)ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BWI CONDUCTED A GENERAL INSPECTION THROUGH THE VISUAL INSPECTION AND ALL FEATURES OF THE CATHETER TESTS. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE C3 EZ STEER CS WITH AUTO ID CATHETER. PER THE EVENT, SEVERAL TESTS WERE PERFORMED. THE MAGNETIC FEATURES WERE TESTED, AND NO ISSUES WERE OBSERVED. IN ADDITION, THE PRODUCT WAS DEFLECTING CORRECTLY. NO MALFUNCTIONS WERE OBSERVED DURING THE PRODUCT ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. AS PART OF BWI¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 69-YEAR-OLD MALE PATIENT (110 KGS) UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB)ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT AFTER THE ABLATION, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. IT WAS DISCOVERED WHILE THE PATIENT WAS STILL ON THE PROCEDURE TABLE, AFTER CATHETER REMOVAL, USING TRANSTHORACIC ECHO. THE CALLER WAS UNCERTAIN IF THE PATIENT'S BLOOD PRESSURE WAS AFFECTED. A PERICARDIOCENTESIS WAS ONGOING AT THE TIME OF THE CALL. THE PATIENT REMAINED STABLE. THE PHYSICIAN DID NOT INDICATE THAT THEY BELIEVED BIOSENSE WEBSTER, INC. PRODUCTS CONTRIBUTED TO THE PATIENT EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THIS ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. PERICARDIOCENTESIS WAS PERFORMED, NO OTHER INTERVENTION NECESSARY. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN, BUT PATIENT WENT HOME. PATIENT STAYED IN HOSPITAL FOR 2 DAYS, WOULD HAVE ONLY BEEN HERE FOR THE DAY IF PROCEDURE WENT ACCORDING TO PLAN. TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE WAS NO KNOWN STEAM POP. THE BIOSENSE WEBSTER REPRESENTATIVE IS NOT SURE WHEN THE EVENT OCCURRED, AS IT WAS NOTICED AFTER THE ABLATION WAS OVER. THE BIOSENSE WEBSTER REPRESENTATIVE SENT ALL CATHETERS BACK BECAUSE THEY WERE NOT SURE WHICH ONE WOULD BE UNDER INVESTIGATION AT THE TIME AND WANTED TO COVER ALL BASES. SINCE SENDING THEM BACK, THE PHYSICIAN HAS STATED SHE SUSPECTS SHE PERFORATED WITH THE CORONARY SINUS CATHETER AT THE BEGINNING OF THE CASE, BUT THEY WERE NEVER ABLE TO GET A DEFINITIVE DIAGNOSIS AS THE CHEST WAS NEVER OPENED. THE BIOSENSE WEBSTER REPRESENTATIVE DOES NOT KNOW WHICH CORONARY SINUS CATHETER IS THE SUSPECTED DEVICE. THEY THINK BOTH WERE USED IN AN ATTEMPT TO GET THE CORONARY SINUS ACCESS BUT CAN NOT REMEMBER THE ORDER THEY WERE USED IN. CONSERVATIVELY THE BWI WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND THE A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER WERE ASSESSED AS MDR REPORTABLE AS ¿THE PHYSICIAN HAS STATED SHE SUSPECTS SHE PERFORATED WITH THE CORONARY SINUS CATHETER AT THE BEGINNING OF THE CASE, BUT THEY WERE NEVER ABLE TO GET A DEFINITIVE DIAGNOSIS AS THE CHEST WAS NEVER OPENED.¿ THEREFORE, IT IS DIFFICULT TO DETERMINE WHICH DEVICE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756086 WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER INC BD710FJ282CT 30342546M 10846835002423

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| H| L NAVISTAR RMT THERMOCOOL| PENTARAY NAV ECO 7FR, D, 2-6-2| REPROCESSED 6FR CS, D, 10 POLE| REPROCESSED 6FR CS, F, 10 POLE| UNK_SMARTABLATE GENERATOR