BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7877345 · Received September 14, 2018

    Report

    Report Number
    2029046-2018-02056
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    August 20, 2018
    Report Date
    August 22, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: 1. NON-BIOSENSE WEBSTER PRODUCT: ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE 2. NON-BIOSENSE WEBSTER PRODUCT: A ST. JUDE MEDICAL AGILIS BIDIRECTIONAL SHEATH 3. BIOSENSE WEBSTER PRODUCT: CARTO® 3 U.S. CATALOG#: FG540000 SERIAL NUMBER: (B)(4). 4. BIOSENSE WEBSTER PRODUCT: SMARTABLATE PUMP KIT-US U.S. CATALOG#: M490008 SERIAL NUMBER: (B)(4). 5. BIOSENSE WEBSTER PRODUCT: SMARTABLATE GENERATOR KIT-US U.S. CATALOG#: M490007 SERIAL NUMBER: (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST-PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FORM THE PERICARDIUM. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS IMPROVED WITH THE EXPECTATION OF FULLY RECOVERY. PATIENT¿S ANATOMY WAS CITED AS A FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT, THE PATIENT HAD A VERY SMALL CHAMBER. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE AND PATIENT ANATOMY-RELATED. THERE WERE NO ERROR MESSAGES OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE AND A ST. JUDE MEDICAL AGILIS BIDIRECTIONAL SHEATH. THE EXACT TIME OF THE INJURY IS UNKNOWN. DURING THE PROCEDURE, 25 WATTS OF POWER WERE APPLIED ON THE POSTERIOR WALL OF THE CHAMBER AND 30 WATTS ON THE ANTERIOR WALL OF THE CHAMBER. THE IRRIGATION WAS SET AT 17ML/MIN AT 30 WATTS OR LESS. THE PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING THE PROCEDURE WITH AN ACTIVATED CLOTTING TIME (ACT) OF 300-350 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717398 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R