BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 14710371 · Received June 16, 2022

    Report

    Report Number
    2029046-2022-01330
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    September 2, 2021
    Report Date
    June 15, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: OKAMATSU H, OKUMURA K, KANEKO S, NEGISHI K, HAYASHI K, TSURUGI T, TANAKA Y, NAKAO K, SAKAMOTO T, KOYAMA J. ABLATION INDEX-GUIDED HIGH-POWER RADIOFREQUENCY APPLICATION SHORTENS THE PROCEDURE TIME WITH SIMILAR OUTCOMES TO CONVENTIONAL POWER APPLICATION IN ATRIAL FIBRILLATION ABLATION. CIRC REP. 2021 SEP 2;3(10):559-568. DOI: 10.1253/CIRCREP.CR-21-0099. PMID: 34703933; PMCID: PMC8492404. 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. 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 REF #: PC-001138378

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: OKAMATSU H, OKUMURA K, KANEKO S, NEGISHI K, HAYASHI K, TSURUGI T, TANAKA Y, NAKAO K, SAKAMOTO T, KOYAMA J. ABLATION INDEX-GUIDED HIGH-POWER RADIOFREQUENCY APPLICATION SHORTENS THE PROCEDURE TIME WITH SIMILAR OUTCOMES TO CONVENTIONAL POWER APPLICATION IN ATRIAL FIBRILLATION ABLATION. CIRC REP. 2021 SEP 2;3(10):559-568. DOI: 10.1253/CIRCREP.CR-21-0099. PMID: 34703933; PMCID: PMC8492404. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: THE IMPACT OF HIGH-POWER RADIOFREQUENCY (RF) APPLICATION IN ABLATION INDEX (AI)-GUIDED ATRIAL FIBRILLATION (AF) ABLATION HAS NOT BEEN ELUCIDATED. METHODS AND RESULTS: WE INVESTIGATED 1,333 PATIENTS UNDERGOING FIRST AF ABLATION (MEDIAN AGE 68 YEARS; INTERQUARTILE RANGE [IQR] 61¿73 YEARS). THE FIRST 301 PATIENTS UNDERWENT AI-GUIDED CONVENTIONAL POWER RF APPLICATION (CP GROUP), WHEREAS THE FOLLOWING 1,032 PATIENTS UNDERWENT HIGH-POWER RF APPLICATION (HP GROUP). THE MINIMUM AI TARGET VALUES WERE 400, 360, AND 260 AT THE LEFT ATRIAL ANTERIOR WALL, POSTERIOR WALL, AND ESOPHAGUS, RESPECTIVELY. RF POWER IN THE CP GROUP WAS 30¿40, 20¿25, AND 20 W AT THE ANTERIOR WALL, POSTERIOR WALL, AND ESOPHAGUS, RESPECTIVELY, COMPARED WITH 50, 40, AND 25, RESPECTIVELY, IN THE HP GROUP. PROCEDURE TIME WAS SHORTER IN THE HP THAN CP GROUP (MEDIAN 153 [IQR 129¿190] VS. 180 (IQR 152¿229) MIN; P<0.0001). THE PERCENTAGE OF FIRST-PASS PULMONARY VEIN ISOLATION (69% VS. 73%; P=0.07) AND ALL PROCEDURE-RELATED COMPLICATIONS (2.0% VS. 3.4%; P=0.19) WAS SIMILAR. KAPLAN-MEIER ANALYSIS SHOWED SIMILAR RECURRENCE-FREE SURVIVAL (RFS) FOR ALL AF TYPES. RESPECTIVE 1-YEAR RFS IN THE CP AND HP GROUPS WAS 82% AND 87% IN PAROXYSMAL AF, 78% AND 82% IN PERSISTENT AF, AND 59% AND 58% IN LONG-STANDING PERSISTENT AF. CONCLUSIONS: IN AI-GUIDED AF ABLATION, HIGH-POWER RF APPLICATION SHORTENS THE PROCEDURE TIME WITHOUT INCREASING COMPLICATIONS AND WITH SIMILAR OUTCOMES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SURROUND FLOW. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: SOUNDSTAR. CARTO3 SYSTEM. PENTARAY NAV CATHETER. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: BEEAT; JAPAN LIFELINE, TOKYO, JAPAN. SL0; ST. JUDE MEDICAL. AGILIS; ST. JUDE MEDICAL). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: PATIENTS SUFFERED PHRENIC NERVE INJURY OCCURRED IN. ALL PHRENIC NERVE INJURIES OCCURRED DURING SVC ISOLATION. ALL PATIENTS EXCEPT FOR 1 WERE ASYMPTOMATIC. 9 PATIENTS SUFFERED GASTRIC HYPOMOTILITY OCCURRED . 6 PATIENTS SUFFERED PERFORATION/ TAMPONADE. 1 PATIENT SUFFERED A STROKE. 6 PATIENTS EXPERIENCED PERICARDITIS THERE WAS NO MENTION OF INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313905 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening AGILIS, ST. JUDE MEDICAL| BEEAT, JAPAN LIFELINE, TOKYO, JAPAN| CARTO3 SYSTEM| PENTARAY NAV CATHETER| SL0, ST. JUDE MEDICAL| SOUNDSTAR