BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15657276 · Received October 24, 2022

    Report

    Report Number
    2029046-2022-02621
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    April 22, 2022
    Report Date
    October 24, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF NO. (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: TANG QH, GUO XG, MA J. A NOVEL ALTERNATING SECOND-GENERATION CRYOBALLOON OR CONTACT-FORCE GUIDED RADIOFREQUENCY CATHETER ABLATION STRATEGY FOR REDO-ABLATION IN PATIENTS WITH RECURRENT ATRIAL FIBRILLATION: A SINGLE-CENTER EXPERIENCE. J INTERV CARD ELECTROPHYSIOL. 2022 AUG 10. DOI: 10.1007/S10840-022-01321-X. EPUB AHEAD OF PRINT. PMID: 35945311. 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 THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: TANG QH, GUO XG, MA J. A NOVEL ALTERNATING SECOND-GENERATION CRYOBALLOON OR CONTACT-FORCE GUIDED RADIOFREQUENCY CATHETER ABLATION STRATEGY FOR REDO-ABLATION IN PATIENTS WITH RECURRENT ATRIAL FIBRILLATION: A SINGLE-CENTER EXPERIENCE. J INTERV CARD ELECTROPHYSIOL. 2022 AUG 10. DOI: 10.1007/S10840-022-01321-X. EPUB AHEAD OF PRINT. PMID: 35945311. OBJECTIVE/METHODS/STUDY DATA: THE PRESENT STUDY AIMED TO INVESTIGATE THE LONG-TERM EFFICACY OF ALTERNATING REVERSE SEQUENCE STRATEGY OF THE TWO ABLATION TECHNIQUES FOR REPEATED AF ABLATION FOLLOWING INDEX ABLATION PROCEDURE. THE AUTHORS RETROSPECTIVELY RECRUITED 156 PATIENTS FROM SEPTEMBER 2016 TO DECEMBER 2019, WHO UNDERWENT FIRST REDO ABLATION AFTER A FAILED INDEX RFC OR 2ND GENERATION CB PVI PROCEDURE IN THIS STUDY. REPEAT ABLATION STRATEGY WAS PERFORMED BY THE ALTERNATING ABLATION TECHNIQUE IN A REVERSE SEQUENCE FROM THE INDEX PVI PROCEDURE. FOR INSTANCE, 60 PATIENTS INITIALLY TREATED WITH 2ND GENERATION CB ABLATION (INDEX CB) UNDERWENT REDO PROCEDURE ABLATION WITH RFC (THE CB- RFC REDO GROUP); 96 PATIENTS INITIALLY TREATED WITH RFC ABLATION (INDEX RFC) UNDERWENT REDO PROCEDURE-ABLATION WITH 2ND GENERATION CB (THE RFCCB REDO GROUP) LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH CATHETER, BIOSENSE WEBSTER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: LASSO , CARTO 3. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: 8.5 FRENCH SL1 TRANSSEPTAL SHEATHS (ST. JUDE MEDICAL INC, (B)(4), USA), 28-MM SECOND-GENERATION CB CATHETER (ART FRONT ADVANCE, MEDTRONIC, (B)(4), USA),15F STEERABLE SHEATH (FLEXCATH, MEDTRONIC, (B)(4), USA), 20-MM-DIAMETER INNER LUMEN ACHIEVE CATHETER (ACHIEVE¿, (B)(4), USA), ACHIEVE MAPPING CATHETER (ACHIEVE MAPPING CATHETER, MEDTRONIC, INC., (B)(4), USA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 2- PHRENIC NERVE PALSY (IN THE RFC-CB REDO GROUP)- NO INTERVENTION MENTIONED. QTY 15- VAGUS REFLEX (6 PATIENTS, IN THE CB-RFC REDO GROUP, 9 PATIENTS IN THE RFC-CB REDO GROUP) - NO INTERVENTION MENTIONED. QTY 2- HEMOPTYSIS (IN THE RFC-CB REDO GROUP) - NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2804544 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 15F STEERABLE SHEATH (FLEXCATH, MEDTRONIC)| 20-MM-DIAMETER INNER LUMEN ACHIEVE CATHETER| 28-MM SECOND-GENERATION CB CATHETER (MEDTRONIC)| 8.5 FRENCH SL1 TRANSSEPTAL SHEATH| ACHIEVE MAPPING CATHETER ( MEDTRONIC)| CARTO 3| LASSO