BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 14132088 · Received April 17, 2022

    Report

    Report Number
    2029046-2022-00824
    Event Type
    Injury
    Date Received
    April 17, 2022
    Date of Event
    March 24, 2022
    Report Date
    May 13, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 20-APR-2022 STATING THE CATHETER WAS DISPOSED OF. THEREFORE, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE INVESTIGATION WAS COMPLETED ON 13-MAY-2022. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR RE-ENTRY TACHYCARDIA (AVRT) AND A WOLFF-PARKINSON-WHITE (WPW) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION. AFTER DOING SOME MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, THE PATIENT¿S PRESSURE DROPPED. THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS USED TO CONFIRM A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND FLUID WAS REMOVED, UNSURE ABOUT HOW MUCH FLUID WAS REMOVED. NO ABLATIONS WERE PERFORMED AS ABLATION CATHETER WAS NEVER INTRODUCED INTO THE PATIENT. PROCEDURE WAS ABORTED. PATIENT IS STABLE CURRENTLY. PHYSICIAN SUSPECTS PERFORATION OCCURRED IN THE RIGHT VENTRICLE (RV) WITH THE CS CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. A BAYLIS TRANSEPTAL NEEDLE WAS USED. THE ABLATION CATHETER WAS NOT EVEN IN THE BODY, SO NO SETTINGS HAD BEEN SELECTED YET. NO ERROR MESSAGES WERE DISPLAYED. THIS COMPLAINT WILL BE CONSERVATIVELY REPORTED UNDER THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER EVEN THOUGH THEY STATE THAT THE PHYSICIAN SUSPECTS PERFORATION OCCURRED IN THE RV WITH THE CS CATHETER, AS IT WAS REPORTED THAT AFTER DOING SOME MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, THE PATIENT¿S PRESSURE DROPPED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. IT WAS CLARIFIED THAT THE CS CATHETER WAS A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS FULLY RECOVERED. THEY STATE THAT THE PATIENT WAS KEPT AT THE HOSPITAL OVERNIGHT; HOWEVER, WAS THEN RELEASED SOON THEREAFTER AND HAS HAD NO COMPLICATIONS THAT THEY ARE AWARE OF. THE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907340 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 Unknown Required Intervention| L CARTO 3 SYSTEM| NON BWI-BAYLIS TRANSSEPTAL NEEDLE| PENTARAY NAV ECO 7FR, F, 2-6-2| UNKNOWN BRAND ABLATION CATHETER| UNKNOWN BRAND ICE CATHETER