BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 4035892 · Received August 25, 2014

    Report

    Report Number
    9673241-2014-00318
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    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® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER 510(K) P030031/ PMA # S053. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ATRIAL TACHYCARDIA PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER AND SUFFERED A PERICARDIAL EFFUSION. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. NO FURTHER INFORMATION IS KNOWN REGARDING THE PATIENT STATUS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511420 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1347-01-S UNKNOWN_D-1347-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening