BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5451713 · Received February 22, 2016

    Report

    Report Number
    9673241-2016-00120
    Event Type
    Injury
    Date Received
    February 22, 2016
    Date of Event
    January 26, 2016
    Report Date
    January 28, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. 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 SMART TOUCH UNIDIRECTIONAL APPROVED UNDER P030031/S053. (B)(4) THE DEVICE WAS NOT RETURNED TO BWI.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17263894M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES.

    Description of Event or Problem · 1

    THIS IS A CLINICAL STUDY. IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL AFIB. ON (B)(6) 2016 AND SUFFERED CARDIAC TAMPONADE THE SAME DAY LATER WHICH WAS TREATED WITH PERICARDIOCENTESIS. THE PATIENT HAD A MEDICAL HISTORY OF HYPERTENSION. THE PATIENT RECEIVED THE ANTICOAGULATION BASED ON HER WEIGHT, ACT WAS NOT MONITORED. THE PRINCIPAL INVESTIGATOR DECLARED THAT THE PATIENT HAD ELEVATED DIASTOLIC BLOOD PRESSURE BUT NO OTHER ABNORMALITIES DURING PROCEDURE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT ARE BWI PRODUCT MALFUNCTION, PROCEDURE, AND PATIENT CONDITION RELATED. HOWEVER NO BWI MALFUNCTION WAS REPORTED. TRANSSEPTAL PUNCTURE WAS PERFORMED USING BRK 407200 ST. JUDE NEEDLE. A 8.5F SL1 ST. JUDE MEDICAL FASTCASH SHEATH WAS USED. IRRIGATED CATHETER WAS USED WITH FLOW SETTING OF 17ML/MIN. GENERATOR PARAMETERS: POWER: 30-40W TEMPERATURE: 43 CELSIUS. DURING THE PROCEDURE, POWER VALUE WAS FROM 30 TO 40 AND THE IMPEDANCE WAS VALUE FROM 110 TO 140, BUT THE TEMPERATURE VALUE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108110 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 OAE BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-04IL-S 17263894M

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R