BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 6583507 · Received May 22, 2017

    Report

    Report Number
    9673241-2017-00383
    Event Type
    Injury
    Date Received
    May 22, 2017
    Date of Event
    April 21, 2017
    Report Date
    April 24, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. CONCOMITANT MEDICAL PRODUCTS: 1.DISTRIBUTED - ACUNAV ULTRASOUND CATHETER; 2. NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE; 3. NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL AGILIS SHEATH; 4. NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SL0 SHEATH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT, IN HER 70S, UNDERWENT AN ABLATION PROCEDURE FOR ATYPICAL ATRIAL FLUTTER WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER TRANSSEPTAL PUNCTURE AND DURING MAPPING, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM (ICE). PERICARDIOCENTESIS YIELDED 800ML. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT OUTCOME. IT WAS NOTED THAT THE INJURY OCCURRED DURING TRANSSEPTAL PHASE WHILE THE ACUNAV ULTRASOUND CATHETER WAS IN USE. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE POSSIBLE SCOLIOSIS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, ASSOCIATED WITH TRANSSEPTAL PUNCTURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE. SHEATHS USED WERE A ST. JUDE MEDICAL AGILIS AND A ST. JUDE MEDICAL SL0. GENERATOR PARAMETERS AND SETTINGS AT THE TIME OF INJURY WERE NOT REPORTED, AS NO ABLATION WAS PERFORMED. OVERALL ABLATION TIME AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WERE NOT REPORTED, AS NO ABLATION WAS PERFORMED. IRRIGATED CATHETER FLOW SETTING WAS NOT REPORTED, AS NO ABLATION WAS PERFORMED. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED BETWEEN 300-350 SECONDS. THERE WERE NO ERROR MESSAGES REPORTED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362218 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1347-02-S UNKNOWN-D1347-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R