BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6617022 · Received June 6, 2017

    Report

    Report Number
    9673241-2017-00437
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 24, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIALLY THE PRINCIPAL INVESTIGATOR ASSESSED THE ADVERSE EVENT OF CONGESTIVE HEART FAILURE (CHF) AS MILD IN SEVERITY. AN UPDATE WAS RECEIVED ON MARCH 12, 2019 STATING THAT THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 19, 2017 THAT PROVIDED AN ADDITIONAL PATIENT CONSEQUENCE OF ATRIAL FLUTTER. POST-PROCEDURE, THE PATIENT DEVELOPED ATYPICAL LEFT ATRIAL FLUTTER. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS NOT SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND POSSIBLY PROCEDURE-RELATED. (B)(4). MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 25, 2017 FOR THE PATIENT CONSEQUENCE OF HEART FAILURE. ORIGINALLY, IT WAS REPORTED THAT THE ISSUE WAS ONGOING AND IMPROVED. UPDATED INFORMATION RECEIVED IS STATING THAT THE ISSUE WAS RESOLVED WITHOUT SEQUELAE. (B)(4)

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUATION: ON POST-PROCEDURE DAY 18, THE PATIENT WAS DIAGNOSED WITH CONGESTIVE HEART FAILURE (CHF). INTERVENTION WAS A CHEST X-RAY AND MEDICATION (UNSPECIFIED). ISSUE IS ONGOING AND IMPROVED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-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. THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17563092L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER, INC., IT WAS REPORTED THAT A (B)(6)MALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER AND SUFFERED POST-PROCEDURAL HEMATURIA RELATED TO THE URINARY CATHETER (REQUIRING PYRIDIUM, SUPPOSITORY, AND CONTINUOUS BLADDER IRRIGATION) AND HEART FAILURE (REQUIRING A CHEST X-RAY AND AN UNSPECIFIED MEDICATION). ON POST-PROCEDURE DAY 0, A URINARY TRACT INJURY RELATED TO THE URINARY CATHETER RESULTED IN HEMATURIA AND PASSING OF BLOOD CLOTS. INTERVENTION WAS MEDICATION (PYRIDIUM AND AN UNSPECIFIED SUPPOSITORY) AND MANUAL AND CONTINUOUS BLADDER IRRIGATION (CBI). PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 9, THE PATIENT WAS ADMITTED VIA THE EMERGENCY DEPARTMENT WITH CONTINUED HEMATURIA AND PASSING OF LARGE BLOOD CLOTS RELATED TO THE URINARY CATHETER SINCE BEING DISCHARGED FROM THE HOSPITAL POST-ABLATION. INTERVENTION WAS MEDICATION (UNSPECIFIED) AND CONTINUOUS BLADDER IRRIGATION (CBI). PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 18, DYSPNEA WAS DIAGNOSED. INTERVENTION WAS A CHEST X-RAY AND MEDICATION (UNSPECIFIED). ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396916 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-SI 17563092L

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R