BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 6173880 · Received December 14, 2016

    Report

    Report Number
    3008203003-2016-00043
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 16, 2016
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A CARTO® 3 SYSTEM AND SUFFERED A CARDIAC TAMPONADE REQUIRING MEDICAL AND SURGICAL INTERVENTION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO A POSSIBLE CARTO 3 SYSTEM ADVANCED CATHETER LOCATION (ACL) MISREPRESENTATION OF THE LOCATION OF THE ST. JUDE MEDICAL CORONARY SINUS (CS) CATHETER. THE ACL DISPLAYED THE CS CATHETER TO BE IN THE SUPERIOR VENA CAVA (SVC), WHEN IT WAS IN THE CS. FIELD SERVICE ENGINEER (FSE) VISITED THE ACCOUNT REGARDING THIS ISSUE. IT WAS FOUND THAT THE ISSUE WAS CAUSED BY A FAULTY NON-BIOSENSE WEBSTER INC. (BWI) CATHETER. THE CATHETER WAS NOT SAVED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO BWI PRODUCTS WERE DETERMINED TO BE AT FAULT. FSE COMPLETED ATP TESTS PER CUSTOMER'S REQUEST. ALL TESTS PASSED. SYSTEM IS UP AND READY FOR USE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: THERMOCOOL SF SMARTTOUCH BI-DIRECTIONAL CATHETER (MODEL# D-1348-05-S). ST JUDE MEDICAL CRD CS CATHETER 6FR (LOT# 5659483). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A CARTO 3 SYSTEM AND SUFFERED A CARDIAC TAMPONADE REQUIRING MEDICAL AND SURGICAL INTERVENTION. DURING THE MAPPING PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR OPEN CHEST EXPLORATORY SURGERY. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT FOR RECOVERY FROM SURGERY. SINCE THEN, THE PATIENT¿S OUTCOME HAS IMPROVED. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO A POSSIBLE CARTO 3 SYSTEM ADVANCED CATHETER LOCATION (ACL) MISREPRESENTATION OF THE LOCATION OF THE ST. JUDE MEDICAL CORONARY SINUS (CS) CATHETER. THE ACL DISPLAYED THE CS CATHETER TO BE IN THE SUPERIOR VENA CAVA (SVC), WHEN IT WAS IN THE CS. NO TROUBLESHOOTING WAS PERFORMED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNSPECIFIED NEEDLE. ST. JUDE MEDICAL AGILIS SHEATH WAS USED. GENERATOR SETTINGS WERE NOT REPORTED. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIMES MAINTAINED AT GREATER THAN 350 SECONDS. NO BWI CATHETERS WERE IDENTIFIED AS BEING RELATED TO THE ADVERSE EVENT. THERE WERE NO ERRORS REPORTED BY THE BIOSENSE WEBSTER SYSTEMS. CORONARY SINUS CATHETER WAS NON-BWI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823709 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R