BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 5824794 · Received July 26, 2016

    Report

    Report Number
    9673241-2016-00455
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 4, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A SMARTTOUCH UNI-DIRECTIONAL SF CATHETER AND SUFFERED HEART BLOCK AV THIRD DEGREE REQUIRING AN IMPLANTATION OF A PACEMAKER. DURING ABLATION, A 3RD DEGREE HEART BLOCK OCCURRED. PATIENT REQUIRED AN IMPLANTATION OF A PACEMAKER. PATIENT WAS REPORTED TO BE IN STABLE CONDITION IMMEDIATELY FOLLOWING THE EVENT. PATIENT REQUIRED HOSPITALIZATION DUE TO THE PACEMAKER IMPLANTATION. IT WAS NOTED THAT IT WAS MOST LIKELY THE FAST PATHWAY THAT WAS DAMAGED DURING ABLATION AND THAT THE HIS BUNDLE REMAINED INTACT AS EVIDENCED BY ITS ABILITY TO TRANSMIT SIGNALS. THE OUTCOME OF THE ADVERSE EVENT IS THAT THE PATIENT HAS IMPROVED. THE PHYSICIANOPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE AND PATIENT CONDITION 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
    474809 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1347-01-S UNKNOWN-D-1347-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R