BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 19741910 · Received July 15, 2024

    Report

    Report Number
    2029046-2024-02355
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    July 28, 2022
    Report Date
    July 16, 2024
    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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WEI Y, CHEN L, CAO J, LIU S, LING T, HUANG X, ZHOU G, LIN C, XIE Y, BAO Y, LUO Q, YE J, ZHANG N, JIN Q, WU L. LONG-TERM OUTCOMES OF A TIME TO ISOLATION - BASED STRATEGY FOR CRYOBALLOON ABLATION COMPARED TO RADIOFREQUENCY ABLATION IN PATIENTS WITH SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION. PACING CLIN ELECTROPHYSIOL. 2022 SEP;45(9):1015-1023. DOI: 10.1111/PACE.14556. EPUB 2022 JUL 28. PMID: 35767472. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 803. 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 #: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 15-JUL-2024. THERE WAS NO RELEVANCE BETWEEN THE HARM AND THE JNJ PRODUCT IN THE ARTICLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WEI Y, CHEN L, CAO J, LIU S, LING T, HUANG X, ZHOU G, LIN C, XIE Y, BAO Y, LUO Q, YE J, ZHANG N, JIN Q, WU L. LONG-TERM OUTCOMES OF A TIME TO ISOLATION - BASED STRATEGY FOR CRYOBALLOON ABLATION COMPARED TO RADIOFREQUENCY ABLATION IN PATIENTS WITH SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION. PACING CLIN ELECTROPHYSIOL. 2022 SEP;45(9):1015-1023. DOI: 10.1111/PACE.14556. EPUB 2022 JUL 28. PMID: 35767472. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: CRYOBALLOON ABLATION (CBA) IS ONE OF THE MOST COMMONLY USED TECHNOLOGIES DESIGNED FOR PULMONARY VEIN ISOLATION (PVI) FOR PAROXYSMAL ATRIAL FIBRILLATION (PAF), ALTHOUGH THE DOSING OF CBA REMAINS CONTROVERSIAL. WE EVALUATED THE LONG-TERM EFFICACY AND SAFETY OF A NOVEL INDIVIDUALIZED STRATEGY OF CBA COMPARED TO RADIOFREQUENCY ABLATION (RFA) FOR PATIENTS WITH PAF. METHODS: IN THIS OBSERVATIONAL STUDY, SYMPTOMATIC PATIENTS WITH DRUG-REFRACTORY PAROXYSMAL AF WERE PROSPECTIVELY CONSENTED AND ENROLLED IN FOUR CENTERS, BEING ASSIGNED EITHER TO THE CBA OR RFA ARM FOR ABLATION. IN THE CBA GROUP, WE USED A TIME TO ISOLATION (TTI) - BASED DOSING PROTOCOL. THE PRIMARY ENDPOINT WAS THE RECURRENCE OF ATRIAL ARRHYTHMIA >30 S FOLLOWING A 90-DAY BLANKING PERIOD. THE SECONDARY ENDPOINT WAS PROCEDURE-RELATED COMPLICATIONS AND PROCEDURE PARAMETERS. RESULTS: A TOTAL OF 500 PATIENTS WERE RECRUITED IN EITHER THE CBA GROUP (N = 247) OR THE RFA GROUP (N = 253) BETWEEN JANUARY 2017 AND JULY 2018. AFTER A MEDIAN FOLLOW-UP OF 778 DAYS, THE ATRIAL TACHYARRHYTHMIA-FREE SURVIVAL WAS 71.7% IN THE CBA GROUP AND 67.0% IN THE RFA GROUP. CBA AND RFA DISPLAYED SIMILAR MAJOR OR MINOR COMPLICATION OCCURRENCE, WHILE THE FORMER HAD A SIGNIFICANTLY SHORTER PROCEDURE DURATION (82.5 MIN VS. 141.1 MIN, P < .001) AND LEFT ATRIAL DWELL TIME (60.1 MIN VS. 109.9 MIN, P < .001) BUT LONGER FLUOROSCOPY EXPOSURE (13.8 MIN VS. 8.1 MIN, P < .001). CONCLUSION: COMPARED TO RFA, OUR TTI-BASED CBA DOSING PROTOCOL SHOWED COMPARABLE EFFICACY AND SAFETY, WITH A SIGNIFICANTLY REDUCED PROCEDURE DURATION IN PATIENTS WITH PAF. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: NAVISTAR RMT THERMOCOOL, LASSO, CARTO3 CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: SHEATHS SL1 SR0 (ST. JUDE MEDICAL), RMN NIOBE ES (STEREOTAXIS INC) A GROIN COMPLICATION TREATED CONSERVATIVELY WAS REPORTED, HOWEVER A NON-BWI SHEATH WAS USED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH: QTY 2: TWO PERICARDIAL EFFUSION REQUIRING DRAINAGE (CARDIAC TAMPONADE) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT). QTY 1: STROKE (CEREBROVASCULAR ACCIDENT) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249635 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L CARTO3.| LASSO.| NAVISTAR RMT THERMOCOOL.| RMN NIOBE ES SHEATH (STEREOTAXIS INC)| SL1 SR0 SHEATH (ST. JUDE MEDICAL).