BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 14091852 · Received April 13, 2022

    Report

    Report Number
    2029046-2022-00782
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    March 18, 2022
    Report Date
    May 4, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT ON 11-APR-2022. THE CATHETER THAT WAS KINKED WAS THE ABBOTT INQUIRY. THE PHYSICIAN DID NOT SPECIFY IF THE ISSUE WAS CAUSED BY THE ABBOTT OR THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. WHEN THE PHYSICIAN WAS ASKED DURING THE FOLLOW UP, HE ONLY MENTIONED THE TRAUMA WITHIN THE CORONARY SINUS WAS LIKELY ¿DUE TO THE CATHETER MANIPULATION WITHIN THE CORONARY SINUS¿ AND THAT IS ALL HE SPECIFIED. THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY DID NOT HAVE A KINK IN IT, WHILE THE OTHER ABBOTT INQUIRY CS CATHETER DID. 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 (B)(6) MALE UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. A CARDIAC TAMPONADE WAS NOTICED WHEN THE PATIENT¿S BLOOD PRESSURE (BP) AND HEART RATE (HR) DROPPED AFTER PACING. THE CARDIAC TAMPONADE WAS DIAGNOSED VIA INTRA CARDIAC ECHO (ICE) CATHETER. A PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN AND THE PATIENT WAS STABLE AT THE TIME OF THE CALL. THE PHYSICIAN HAD ISSUES ADVANCING THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AT THE BEGINNING OF THE PROCEDURE. THE CATHETER WAS EXCHANGED FOR AN INQUIRY (ABBOTT) CATHETER WHICH ENDED UP KINKED NEAR THE IVC (SEEN ON FLUORO). THE PHYSICIAN BELIEVES THAT CATHETER MANIPULATION WITHIN THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY MAY HAVE BEEN THE CAUSE. THE ADVERSE EVENT WAS DISCOVERED DURING USE BIOSENSE WEBSTER PRODUCTS. POST PERICARDIOCENTESIS, THE PATIENT STABILIZED AND THE PATIENT WAS REMOVED FROM THE ROOM. THE GENERATOR USED WAS A SMARTABLATE GENERATOR KIT-US. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A VERSACROSS SYSTEM. THERE WAS NO KNOWN ISSUE WITH THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. IT WAS BRIEFLY USED BEFORE BEING REPLACED WITH AN INQUIRY CS CATHETER. PRIOR TO NOTING THE CARDIAC TAMPONADE ABLATION WAS PERFORMED AND THERE WAS NO EVIDENCE OF A STEAM POP. IF IT DID OCCUR WITH CS MANIPULATION, IT WOULD HAVE BEEN AT THE BEGINNING OF THE CASE. THIS WOULD MAKE THE MOST SENSE AS THE PATIENT STEADILY STRUGGLED MORE AND MORE TO MAINTAIN BLOOD PRESSURE THROUGHOUT THE PROCEDURE. THE CARDIAC TAMPONADE WAS DISCOVERED DURING ABLATION PHASE OF THE PROCEDURE. AN IRRIGATED CATHETER WAS USED AND THE SMART TOUCH SF FLOW RATE WAS 2ML/MIN IDLE FLOW, 8ML/MIN <30 WATTS LOW FLOW & 15ML/MIN >30 WATTS HIGH FLOW. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. FORCE VISUALIZATION USED WAS GRAPH WITH THE VISITAG MODULE PARAMETERS FOR STABILITY SET TO 2-3MM, 3SEC, 25%, 3MM WITH NO ADDITIONAL FILTER USED. BASED ON THE AVAILABLE INFORMATION, THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WILL BOTH BE REPORTABLE AS ABLATION WAS PERFORMED AND THE PHYSICIAN FELT THAT CATHETER MANIPULATION WITHIN THE CORONARY SINUS MAY HAVE BEEN THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939584 WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention| L NON BWI-ABBOTT INQUIRY CS CATHETER| NON BWI-VERSACROSS SYSTEM| SMARTABLATE GENERATOR KIT-US| THMCL SMTCH SF BID, TC, D-F| UNKNOWN BRAND ICE CATHETER| UNKNOWN BRAND PUMP| UNK_CARTO 3