BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 6652389 · Received June 19, 2017

    Report

    Report Number
    9673241-2017-00491
    Event Type
    Injury
    Date Received
    June 19, 2017
    Date of Event
    April 24, 2017
    Report Date
    April 25, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    1084683500978
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUATION: TITRATION. OVERALL ABLATION TIME AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WERE NOT REPORTED, AS NO ABLATION WAS PERFORMED AT THE SITE OF INJURY. IRRIGATED CATHETER FLOW WAS SET AT 8ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIMES MAINTAINED BETWEEN 250-300 SECONDS. ERRORS INCLUDED ¿ERROR 20¿ ON POLE A AND ¿STIMULATION ROUTING DISABLED.¿ PACING WAS PLANNED. PACING LEADS WERE CONNECTED TO THE CARTO 3 PIU PRIMARY PACING PORT. CARTO DID NOT ALLOW PACING DURING ABLATION. THERE WAS NO UNWANTED PACING BEING DELIVERED. THE MICROPACE EPS320 STIMULATOR WAS BEING USED DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE OR CATHETER PROXIMITY. CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO® 3 PATIENT INTERFACE UNIT. CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. ORIGINALLY THIS EVENT WAS REPORTED UNDER THE PENTARAY NAVIGATIONAL ECO CATHETER (MANUFACTURER¿S REFERENCE NO. (B)(4)) AS MULTIPLE ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION ON THE BIOSENSE WEBSTER, INC. CATHETERS USED DURING THE PROCEDURE. HOWEVER, NO FURTHER INFORMATION HAD BEEN MADE AVAILABLE. WITH THE INFORMATION AVAILABLE, WE REPORTED THIS EVENT UNDER THE PENTARAY NAVIGATIONAL ECO CATHETER. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON MAY 22, 2017 PROVIDING THE SMART TOUCH UNIDIRECTIONAL SF CATHETER INFORMATION AS IT WAS ALSO USED IN THE PROCEDURE. THE ASSESSMENT WAS MADE TO ALSO REPORT THIS EVENT UNDER THIS RELATED SMART TOUCH UNIDIRECTIONAL SF CATHETER. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. CONCOMITANT PRODUCTS: NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL BRK-1 XS CURVE (ADULT) TRANSSEPTAL NEEDLE. NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL 8 FRENCH SL0 SHEATH. PENTARAY NAVIGATIONAL ECO CATHETER (SECOND PENTARAY NAVIGATIONAL ECO CATHETER USED IN THE PROCEDURE), MODEL #: D-1282-08-S, LOT #: 17630162L. C3 ECO INTERFACE CABLE, MODEL #: D-1344-01-S, LOT: 17632064L. BOSTON SCIENTIFIC MICROPACE CARDIAC STIMULATOR (EPS320). BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH UNIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. WHEN THE PENTARAY NAVIGATIONAL ECO CATHETER WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU), A CATHETER SENSOR ERROR (ERROR 20 ON POLE A) APPEARED AND THE LED 'ECG OUT' TURNED RED. THE CABLE AND DONGLE WERE REPLACED AND THE ISSUE PERSISTED. THE PENTARAY NAVIGATIONAL ECO CATHETER WAS REPLACED WITH ANOTHER CATHETER AND THE ISSUE RESOLVED. ONE HOUR POST CATHETER REPLACEMENT, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA TRANSESOPHAGEAL ULTRASOUND. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED AMOUNT OF FLUID. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL REPAIR OF THE RIGHT ATRIUM. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT FULLY RECOVERED. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. IT WAS NOTED THAT THE CATHETER SENSOR ERROR WAS NOT RELATED TO THE ADVERSE EVENT, THE ADVERSE EVENT WAS NOT CAUSED BY THE BIOSENSE WEBSTER, INC. CATHETER, AND NO BIOSENSE WEBSTER, INC. PRODUCTS WERE USED AT THE SITE OF INJURY. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT THE TAMPONADE LIKELY OCCURRED DURING TRANSSEPTAL PUNCTURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK-1 XS CURVE (ADULT) TRANSSEPTAL NEEDLE. SHEATH USED WAS A ST. JUDE MEDICAL 8 FRENCH SL0. GENERATOR PARAMETERS INCLUDED POWER CONTROL MODE WITH THERMOCOOL SF CUT-OFF VALUES AND TEMPERATURE CUT-OFF OF 40 DEGREES CELSIUS. THERE IS NO INFORMATION REGARDING GENERATOR SETTINGS AT THE TIME OF INJURY. THERE IS NO INFORMATION REGARDING POWER... EVENT DESCRIPTION TO BE CONTINUED...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431114 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1347-02-S 17613736L 1084683500978

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R