BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7741535 · Received August 1, 2018

    Report

    Report Number
    2029046-2018-01886
    Event Type
    Injury
    Date Received
    August 1, 2018
    Date of Event
    July 6, 2018
    Report Date
    July 6, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17763799M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: NON-BIOSENSE WEBSTER, INC.: ST. JUDE MEDICAL BRK XS 71 CM. NON-BIOSENSE WEBSTER, INC.: ST. JUDE MEDICAL BRK XS 89 CM. NON-BIOSENSE WEBSTER, INC.: ST. JUDE MEDICAL AGILIS SL1 SHEATH. SMARTABLATE GENERATOR, US CATALOG #: UNKNOWN,. SERIAL #: UNKNOWN. CARTO 3 SYSTEM, US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. PRE-PROCEDURE, PERICARDIAL EFFUSION WAS NOTED IN THE INTRACARDIAC ULTRASOUND. THE EFFUSION BECAME LARGER AT THE END OF THE ABLATION. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE THE FLUID FROM PERICARDIUM. TOWARDS THE END OF THE CASE, WHILE POST-PACING, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND THE ANESTHETIC NURSE ADMINISTERED NEO (PHENYLEPHRINE INJECTION) TO THE PATIENT BUT DID NOT NOTIFY THE PHYSICIAN AT THE TIME. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU). EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE ADVERSE EVENT WAS CONSIDERED AS LIFE THREATENING; HOWEVER PATIENT OUTCOME IS IMPROVED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION; HOWEVER, HE DOES NOT BELIEVE THAT THE ADVERSE EVENT WAS SECONDARY TO RADIOFREQUENCY (RF) DELIVERY. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK XS 71 CM AND BRK XS 89 CM TRANSSEPTAL NEEDLES AND A ST. JUDE MEDICAL AGILIS SL1 SHEATHS. THE PHYSICIAN ABLATED AT 25 WATTS POSTERIOR LEFT ATRIUM (LA) AND ROOF AND 30-35 WATTS ANTERIOR RIDGE AND SEPTAL. THE TEMPERATURE NEVER REACHED MAX THRESHOLD OF SAFETY. PHYSICIAN USED THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AT RECOMMENDED FLOW RATES AS SET BY WATTS. NO ABNORMAL IMPEDANCE OR DELTA CHANGES WERE IDENTIFIED DURING ABLATION. STABLE CATHETER FORCE READINGS WERE NOTED THROUGHOUT THE ABLATION. POWER DID NOT TITRATE DURING THE ABLATION AS THE PHYSICIAN USED SINGLE LESION SPOT RF FOR 30-60 SECONDS DEPENDING ON LOCATION. THE OVERALL TIME FOR ABLATION AT THE SITE OF INJURY WAS 39 MINUTES. THE LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WAS 30 SECONDS. PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING THE PROCEDURE. THE ACTIVATED CLOTTING TIME (ACT) WAS MONITORED DURING THE ENTIRETY OF THE CASE AND MAINTAINED AT A THERAPEUTIC LEVEL OF 300-400 SECONDS. THE PATIENT WAS GIVEN HEPARIN BONUS AND DRIP DURING CASES WHICH WAS REVERSED WHEN PERICARDIAL EFFUSION WAS NOTED. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE. THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY WITH ANY CATHETER. THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT (PIU). THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582639 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 17763799M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R