BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15705291 · Received October 31, 2022

    Report

    Report Number
    2029046-2022-02700
    Event Type
    Injury
    Date Received
    October 31, 2022
    Date of Event
    October 3, 2022
    Report Date
    October 31, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 30850667L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 75-YEAR-OLD MALE PATIENT, WEIGHING 56KG, UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED HEART BLOCK REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT AV BLOCK OCCURRED WHILE CONDUCTING SLOW PATHWAY (SP) ABLATION. THERE WAS A DISCREPANCY IN ATRIOVENTRICULAR (A-V), AND THE PATIENT WAS FOLLOWED UP FOR ABOUT 20 MINUTES BECAUSE ISP WAS ADMINISTERED. HOWEVER, THE PATIENT'S PULSE DID NOT RETURN, SO A TEMPORARY PACEMAKER IMPLANTATION WAS PERFORMED. THE PATIENT RETURNED TO THE WARD. IMMEDIATELY BEFORE LEAVING THE CATHETER¿S ROOM, THE PATIENT'S PULSE RETURNED TO SINUS RHYTHM. P WAVE ALSO RETURNED TO NORMAL VALUE WHILE THE PATIENT WAS IN THE WARD, AND THE PATIENT WAS FOLLOWED UP ON THE NEXT DAY. THIS EVENT OCCURRED WHEN CONDUCTING ABLATION AT A SITE THAT IS ¿1.8 CM AWAY FROM HIS RECORDING SITE IN CS OS¿. THE PHYSICIAN'S OPINION REGARDING THE EVENT WAS THAT THERE WAS NO RELATIONSHIP WITH THE PRODUCT AND THE EVENT. THE PHYSICIAN ALSO COMMENTED THAT THE PATIENT ORIGINALLY HAD A LONG DISTANCE BETWEEN THE HIS BUNDLE AND ATRIOVENTRICULAR NODE, AND THEREFORE, THE ABLATION AT SLOW PATHWAY SITE WAS RESULTING IN HEART BLOCK DUE TO WEAKENED CONDUCTION OF THE ORIGINAL CONDUCTION SYSTEM. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060232 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134801 30850667L 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention PENTARAY NAV ECO 7FR, D, 2-6-2.| SOUNDSTAR ECO GE 8F CATHETER.| UNK_SMARTABLATE GENERATOR.