BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6652668 · Received June 19, 2017

    Report

    Report Number
    9673241-2017-00495
    Event Type
    Injury
    Date Received
    June 19, 2017
    Date of Event
    May 7, 2017
    Report Date
    May 31, 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

    INITIALLY IT WAS REPORTED THAT THERE WAS NO INFORMATION REGARDING INTERVENTIONS OR EXTENDED HOSPITALIZATION. SINCE IT HAD NOT BEEN CONFIRMED IF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION WAS REQUIRED FOR THE TREATMENT OR PREVENTION OF PERMANENT DAMAGE TO THE PATIENT, THIS EVENT WAS ASSESSED AS MDR REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 18, 2019. IT WAS REPORTED THAT THE PATIENT WAS A 71 YEAR OLD MALE. THE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE. THE PATIENT SUFFERED A URINARY INFECTION REQUIRING MEDICATION. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. SINCE IT WAS CONFIRMED THAT MEDICAL/SURGICAL INTERVENTION WAS REQUIRED FOR THE TREATMENT OR PREVENTION OF PERMANENT DAMAGE TO THE PATIENT, THIS EVENT WAS ASSESSED MDR REPORTABLE. THEREFORE, POPULATED, PATIENT AGE AT THE TIME OF EVENT, AGE UNIT AND SEX FIELDS. LEGACY MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ORIGINALLY, THE PRODUCT REPORTED WAS A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER / MODEL #: D-1327-00-S / LOT #: UNKNOWN_D-1327-00-S. ADDITIONAL CLARIFICATION WAS RECEIVED ON SEPTEMBER 4, 2017 PROVIDING A CORRECTED PRODUCT. THE CORRECT PRODUCT IS THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER / MODEL #: D-1327-05-S/LOT #: UNK_D-1327-05-S. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. (B)(4).

    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL, SPONSORED BY BIOSENSE WEBSTER, INC., A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER AND SUFFERED A URINARY INFECTION. ON POST-PROCEDURE DAY 2, THE PATIENT DEVELOPED A URINARY TRACT INFECTION. THERE IS NO INFORMATION REGARDING INTERVENTIONS OR EXTENDED HOSPITALIZATION. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, NOT DEVICE-RELATED, AND PROBABLY PROCEDURE-RELATED. SINCE IT HAS NOT BEEN CONFIRMED IF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION WAS REQUIRED FOR THE TREATMENT OR PREVENTION OF PERMANENT DAMAGE TO THE PATIENT, THIS EVENT IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431455 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-00-S UNKNOWN_D-1327-00-S

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other