BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THMCL SMTCH SF BID, TC, D-F

    MDR report key: 8888613 · Received August 13, 2019

    Report

    Report Number
    2029046-2019-03542
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    October 4, 2018
    Report Date
    October 9, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS WERE IDENTIFIED. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE ON (B)(6) 2018 WITH A THERMOCOOL SMART TOUCH SF BIDIRECTIONAL (STSF) CATHETER AND DEVELOPED BRADYCARDIA AND HYPOTENSION REQUIRING MEDICATION. DURING THE PROCEDURE, THE STSF CATHETER WAS USED FOR ABLATION. RADIO FREQUENCY (RF) OF 115 APPLICATIONS WAS DELIVERED. NO DEVICE DEFICIENCIES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH NO IMMEDIATE PATIENT CONSEQUENCES. ON POST-PROCEDURE DAY 0 ((B)(6) 2018), THE PATIENT DEVELOPED BRADYCARDIA. AN UNSPECIFIED MEDICATION WAS ADMINISTERED. EXTENDED HOSPITALIZATION OF (3 DAYS) WAS REQUIRED AS A RESULT OF THE EVENT. THE ISSUE WAS THEN RESOLVED. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE, SERIOUS, NOT RELATED TO THE INVESTIGATIONAL DEVICE (STSF), NOT RELATED TO THE STUDY CATHETERS, NOT RELATED TO THE BIOSENSE WEBSTER INC. (BWI) NON-INVESTIGATIONAL DEVICE AND PROBABLE INDEX PROCEDURE RELATED. ON POST-PROCEDURE DAY 0 ((B)(6) 2018), THE PATIENT DEVELOPED HYPOTENSION. AN UNSPECIFIED MEDICATION WAS ADMINISTERED. EXTENDED HOSPITALIZATION (3 DAYS) WAS REQUIRED AS A RESULT OF THE EVENT. ISSUE WAS RESOLVED. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE, SERIOUS, NOT RELATED TO THE INVESTIGATIONAL DEVICE (STSF), NOT RELATED TO THE STUDY CATHETERS, NOT RELATED TO THE BWI NON-INVESTIGATIONAL DEVICE AND PROBABLE INDEX PROCEDURE RELATED. ON POST-PROCEDURE DAY 8 ((B)(6) 2018), THE PATIENT DEVELOPED FATIGUE. AN UNSPECIFIED MEDICATION WAS ADMINISTERED. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. ISSUE WAS RESOLVED. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, NOT RELATED TO THE INVESTIGATIONAL DEVICE (STSF), NOT RELATED TO THE STUDY CATHETERS, NOT RELATED TO THE BWI NON-INVESTIGATIONAL DEVICE AND POSSIBLE INDEX PROCEDURE RELATED. UNRELATED PATIENT EVENT: POST-PROCEDURE DAY 15 ((B)(6) 2018), THE PATIENT DEVELOPED BILATERAL LOWER EXTREMITY (BLE) EDEMA. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, NOT RELATED TO THE INVESTIGATIONAL DEVICE (STSF), NOT RELATED TO THE STUDY CATHETERS, NOT RELATED TO THE BWI NON-INVESTIGATIONAL DEVICE AND UNLIKELY RELATED TO THE INDEX PROCEDURE; THEREFORE, THIS EVENT WILL NOT BE CODED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681242 THMCL SMTCH SF BID, TC, D-F CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30077227L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R