BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6639870 · Received June 14, 2017

    Report

    Report Number
    9673241-2017-00471
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    May 20, 2017
    Report Date
    May 22, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 08, 2018. PATIENT WAS A (B)(6) FEMALE. PROCEDURE WAS PAROXYSMAL ATRIAL FIBRILLATION. THE PATIENT REQUIRED EMBOLIZATION THROMBIN PSEUDOANEURYSM. IN ADDITION, THE PATIENT REQUIRED 5 DAYS OF EXTENDED HOSPITALIZATION. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE RELATED, MODERATE IN SEVERITY. THE OUTCOME IS RESOLVED WITHOUT SEQUELAE. (B)(4).

    Additional Manufacturer Narrative · 1

    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. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 07/28/2017 FROM (B)(6) THAT THIS ACCOUNT ((B)(6)) USES A SMARTTOUCH CATALOG # D132705. PER THE ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS UPDATED FROM SMART TOUCH UNIDIRECTIONAL CATALOG# D133600 TO SMART TOUCH BIDIRECTIONAL CATALOG# D132705. THE LOT NUMBER REMAINS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BWI, IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A LEFT GROIN VASCULAR PSEUDOANEURYSM. THERE IS NO INFORMATION REGARDING INTERVENTIONS OR EXTENDED HOSPITALIZATION. ISSUE IS ONGOING AND HAS IMPROVED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SERIOUS, UNLIKELY DEVICE-RELATED, AND DEFINITELY PROCEDURE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421765 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other