BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    MDR report key: 11958963 · Received June 8, 2021

    Report

    Report Number
    2029046-2021-00885
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 2, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    PMA / PMN Number
    K170997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/9/2021, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION INDICATING THE TRANSSEPTAL PUNCTURE WAS DONE WITH AN SJM SL1 SHEATH AND A BAYLIS NEEDLE. AS SUCH, UPDATED THE BAYLIS SL1 SHEATH TO ST. JUNE MEDICAL SL1 SHEATH UNDER D10. CONCOMITANT MED. PRODUCTS SECTION. ON 6/18/2021, IT WAS ALSO CONFIRMED THAT THE BWI SHEATH THAT WAS IN USE DURING THIS CASE WAS A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM. AS SUCH, THE FOLLOWING UPDATES HAVE BEEN PROCESSED: D1. BRAND NAME HAS BEEN UPDATED FROM CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH TO CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; D4. CATALOG # FIELD HAS BEEN UPDATED FROM UNK_CARTO VIZIGO SHEATH TO D138502; D4. UNIQUE IDENTIFIER( UDI) HAS BEEN POPULATED WITH (B)(4); G4. PMA/ 510(K) HAS BEEN POPULATED WITH K170997 4. PMA/ 510(K) IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A 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 REF. # (B)(4)

    Additional Manufacturer Narrative · 1

    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. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT ((B)(6) KG, 5.5 FT) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING THE PROCEDURE, TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS SL1 SHEATH AND NEEDLE. THE NEEDLE CROSSED THE SEPTUM. THE SL1 SHEATH WAS THEN REPLACED WITH A VIZIGO SHEATH AND A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS PLACED INTO THE LEFT ATRIUM. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER THEN SHOWED A ¿CATHETER SENSOR ERROR¿ ON THE CARTO 3 SYSTEM. THE CABLE WAS SWITCHED BUT THE ISSUE REMAINED. THE CATHETER WAS REMOVED FROM THE BODY IN ORDER TO BE REPLACED; HOWEVER, NO OTHER CATHETER WAS INSERTED AS THE PATIENT BECAME HYPOTENSIVE AND PERICARDIAL EFFUSION WAS CONFIRMED VIA ULTRASOUND AND INTRACARDIAC ECHO (ICE). PERICARDIOCENTESIS WAS DONE TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. AFTER DRAINAGE, THE PATIENT WAS SENT TO OPERATING ROOM FOR OPEN HEART SURGERY TO REPAIR THE PERFORATION ON THE LEFT ATRIAL APPENDAGE (LAA). PATIENT WAS REPORTED IN STABLE CONDITION AND HAD FULLY RECOVERED. THERE¿S NO REPORT OF PROLONGED HOSPITALIZATION. PHYSICIAN¿ OPINION IS THAT THE PERFORATION OCCURRED WITH THE BAILYS NEEDLE DURING THE INITIAL PUNCTURE THROUGH THE SL1 SHEATH AND NOT RELATED TO ANY BWI PRODUCT. NO ABLATION WAS EVER DONE. ON 5/14/2021, IT WAS CLARIFIED AND DETERMINED THAT BECAUSE THE CARTO VIZIGO SHEATH WAS USED AFTER THE TRANSSEPTAL PUNCTURE PROCEDURE WAS COMPLETED, THE EXCHANGE FOR THE CARTO VIZIGO SHEATH COULD HAVE ALSO GENERATED A CARDIAC PERFORATION. ALTHOUGH PHYSICIAN¿ OPINION IS THAT THE PERFORATION OCCURRED WITH THE BAILYS NEEDLE DURING THE INITIAL PUNCTURE THROUGH THE SL1 SHEATH AND NOT RELATED TO ANY BWI PRODUCT, IT HAS BEEN DETERMINED THAT THE CARTO VIZIGO SHEATH COULD HAVE CONTRIBUTED TO THE ADVERSE EVENT. AS SUCH THIS EVENT IS BEING REPORTED UNDER THE CARTO VIZIGO SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858202 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R BAYLIS NEEDLE| BAYLIS SL1 SHEATH| CARTO 3 SYSTEM| SL0 WIRE (NON-BWI)| ST. JUNE MEDICAL SL1 SHEATH| THMCL SMTCH SF BID, TC, D-F| BAYLIS NEEDLE| BAYLIS SL1 SHEATH| CARTO 3 SYSTEM| SL0 WIRE (NON-BWI)| THMCL SMTCH SF BID, TC, D-F