BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6371066 · Received March 1, 2017

    Report

    Report Number
    9673241-2017-00169
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    January 31, 2017
    Report Date
    January 31, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAINTAINED IN AN UNSPECIFIED RANGE. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE (SPI) VALUE OR CATHETER PROXIMITY. THE THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE, POST-CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT. THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THERE WERE NO ERROR MESSAGES ON ANY BIOSENSE WEBSTER INC. EQUIPMENT DURING THE PROCEDURE. THERE WERE NO EQUIPMENT ISSUES OR PRODUCT MALFUNCTIONS NOTED 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. 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 PRODUCTS: PENTARAY NAVIGATIONAL ECO CATHETER: MFG #: D-1282-11-S, LOT #: UNKNOWN. WEBSTER CORONARY SINUS WITH AUTO ID CATHETER: MFG #: D-1353-04-S, LOT #: UNKNOWN. CARTO 3 SYSTEM: MFG #: M-4800-01, SERIAL #: (B)(4). STOCKERT 70 SYSTEM: MFG #: M-5463-01, SERIAL #: (B)(4). COOLFLOW PUMP: MFG: M-5491-02, SERIAL #: (B)(4). NON BIOSENSE WEBSTER INC. - ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE. NON BIOSENSE WEBSTER INC. - ST. JUDE MEDICAL SL0 8.5 FRENCH SHEATH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR LEFT ATRIAL FLUTTER WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. ON POST-PROCEDURE DAY 6, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A TAMPONADE. THE PERICARDIOCENTESIS YIELDED 1300ML OF FLUID. THERE IS NO INFORMATION REGARDING WHEN THE ADVERSE EVENT OCCURRED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT IS EXPECTED TO BE DISCHARGED 3 DAYS POST-ADMISSION. THERE IS NO INFORMATION REGARDING PATIENT OUTCOME. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS NOT A RESULT OF CATHETER ABLATION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE. SHEATH IN USE WAS A ST. JUDE MEDICAL SL0 8.5 FRENCH. GENERATOR PARAMETERS, OVERALL ABLATION TIME, AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WERE NOT REPORTED, AS THE SITE OF INJURY IS UNKNOWN. IT WAS ALSO NOTED THAT THE CAUSE OF INJURY IS UNKNOWN. THERE IS NO INFORMATION REGARDING POWER TITRATION. IRRIGATED CATHETER FLOW WAS SET AT 17ML/MIN OR 30ML/MIN, DEPENDING ON THE POWER SETTING. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150589 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R