BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 5717740 · Received June 10, 2016

    Report

    Report Number
    9673241-2016-00368
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 17, 2016
    Report Date
    May 18, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL SMARTTOUCH APPROVED UNDER P030031/S053. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). STOCKERT GENERATOR, MODEL #: 39D-76X, SERIAL #: (B)(4). COOLFLOW PUMP, MODEL #: M-5491-01, SERIAL #:(B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR FASCICULAR VENTRICULAR TACHYCARDIA WITH A SMARTTOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS AND PERICARDIAL DRAIN. DURING THE PROCEDURE, A CARDIAC TAMPONADE WAS DISCOVERED AND A PERICARDIOCENTESIS YIELDED AN UNKNOWN AMOUNT OF FLUID. A PERICARDIAL DRAIN WAS LEFT IN PLACE. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. IT WAS NOTED THAT THE ADVERSE EVENT WAS FELT TO BE UNRELATED TO BWI PRODUCTS. THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. 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
    371773 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S UNKNOWN_D-1348-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R