BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 9359820 · Received November 21, 2019

    Report

    Report Number
    2029046-2019-03913
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    October 29, 2019
    Report Date
    October 29, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    INITIALLY, THE HRA CATHETER WAS REPORTED AS AN ¿UNKNOWN BRAND HRA CATHETER¿. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 25, 2019 STATING THAT THE HRA CATHETER IS A BIOSENSE WEBSTER, INC. AUTO ID QUAD. THEREFORE, UPDATED ¿D11. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES¿ TO REFLECT THIS PRODUCT TO A ¿UNK_C3 WEBSTER QUADRAPOLAR WITH AUTO ID ¿ FIXED¿ FROM ¿UNKNOWN BRAND HRA CATHETER¿. IN ADDITION, INITIALLY, THIS EVENT WAS CONSERVATIVELY REPORTED UNDER THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. HOWEVER, PER THE ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 25, 2019 CLARIFYING THAT THE ¿UNKNOWN BRAND HRA CATHETER¿ WAS A BIOSENSE WEBSTER, INC. ¿UNK_C3 WEBSTER QUADRAPOLAR WITH AUTO ID ¿ FIXED¿, THIS EVENT WILL ALSO CONSERVATIVELY BE REPORTED UNDER THE ¿UNK_C3 WEBSTER QUADRAPOLAR WITH AUTO ID ¿ FIXED¿. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS THREE COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, POST ABLATION PHASE AND POST USE OF BIOSENSE WEBSTER PRODUCTS, A CARDIAC TAMPONADE WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE CARDIAC TAMPONADE WAS CONFIRMED BY ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND 1700 CC OF FLUID WAS REMOVED. THE PATIENT¿S BLOOD PRESSURE BECAME NORMAL AFTER THE HRA CATHETER WAS REMOVED FROM THE HEART. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. EXTENDED HOSPITALIZATION WAS REQUIRED BECAUSE THE PATIENT WAS SENT TO THE OPERATING ROOM. IT IS UNKNOWN IF SURGICAL INTERVENTION WAS PERFORMED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT MAY BE BECAUSE OF THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY OR THE AWKWARD PLACEMENT OF THE ATRIAL LEAD WHICH SEEMED TO MAKE CATHETER MANEUVERABILITY DIFFICULT. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. ABLATION WAS PERFORMED PRIOR TO NOTICING THE CARDIAC TAMPONADE. THERE WAS NO EVIDENCE OF A STEAM POP. FLOW SETTING WAS 30 ML/MIN DURING ABLATION. GRAPH, DASHBOARD AND VISITAG VISUALIZATION FEATURES WERE USED. VISITAG PARAMETERS WERE RANGE 2 MM, MAX DISTANCE CHANGE, 3 SECOND MINIMUM TIME, FORCE OVER TIME 25% OVER 5 GRAMS, 3 MM TAG SIZE AND TAG INDEX COLOR OPTION. ADDITIONAL ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS EVENT WILL BE CONSERVATIVELY REPORTED UNDER THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151099 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 38 YR Hospitalization| L| R CARTO 3 SYSTEM| THMCL SMRTTCH,BI,NAV,TC,D-F,C3| UNKNOWN BRAND HRA CATHETER| UNK_C3 WEBSTER QUADRAPOLAR WITH AUTO ID - FIXED