BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_THERMOCOOL SF NAV

    MDR report key: 19150478 · Received April 22, 2024

    Report

    Report Number
    2029046-2024-01320
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    August 24, 2022
    Report Date
    April 22, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: FRANCKE A, NAUMANN G, WEIDAUER MC, SCHARFE F, SCHOEN S, WUNDERLICH C, CHRISTOPH M. ESOPHAGEAL SAFETY IN CLOSE-GUIDED 50¿W HIGH-POWER-SHORT-DURATION PULMONARY VEIN ISOLATION: THE PREHEAT-PVI-REGISTRY. J CARDIOVASC ELECTROPHYSIOL. 2022 NOV;33(11):2276-2284. DOI: 10.1111/JCE.15656. EPUB 2022 AUG 24. PMID: 35979645. 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. 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: FRANCKE A, NAUMANN G, WEIDAUER MC, SCHARFE F, SCHOEN S, WUNDERLICH C, CHRISTOPH M. ESOPHAGEAL SAFETY IN CLOSE-GUIDED 50¿W HIGH-POWER-SHORT-DURATION PULMONARY VEIN ISOLATION: THE PREHEAT-PVI-REGISTRY. J CARDIOVASC ELECTROPHYSIOL. 2022 NOV;33(11):2276-2284. DOI: 10.1111/JCE.15656. EPUB 2022 AUG 24. PMID: 35979645. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: PULMONARY VEIN ISOLATION (PVI) USING HIGH-POWER-SHORT-DURATION (HPSD) RADIOFREQUENCY ABLATION (RF) IS EMERGING AS THE STANDARD OF CARE FOR TREATMENT OF ATRIAL FIBRILLATION (AF). WHILE PROCEDURAL SHORT-TERM TO MIDTERM EFFICACY AND EFFICIENCY ARE VERY PROMISING, THIS REGISTRY AIMS TO INVESTIGATE ESOPAHGEAL SAFETY USING AN OPTIMIZED ABLATION APPROACH. METHODS: IN A SINGLE-CENTER EXPERIENCE, (B)(4) CONSECUTIVE STANDARDIZED FIRST-TIME AF ABLATION WERE PERFORMED USING A CLOSE-GUIDED-FIXED-50 W-CIRCUMFERENTIAL PVI AND SUBSTRATE MODIFICATION WITHOUT INTRAPROCEDURAL ESOPHAGEAL TEMPERATURE MEASUREMENT. THREE HUNDRED PATIENTS UNDERWENT POSTPROCEDURAL ESOPHAGEAL ENDOSCOPY TO DIAGNOSE AND GRADE ENDOSCOPICALLY DETECTED ESOPHAGEAL LESIONS (EDEL) AND WERE INCLUDED IN THE ANALYSIS. RESULTS: EDEL WERE DETECTED IN (B)(4), (B)(4) WERE LOW-GRADE (B)(6)-CLASSIFICATION (KCC) 1 LESIONS WITH FAST HEALING TENDENCIES. (B)(4) PATIENTS SUFFERED KCC 2A LESIONS, (B)(4). NO ESOPHAGEAL PERFORATION OR FISTULA FORMATION WAS OBSERVED. PATIENT BASELINE CHARACTERISTICS, ESPECIALLY PATIENTS AGE, GENDER, AND BODY MASS INDEX DID NOT INFLUENCE EDEL INCIDENCE. ADDITIONAL POSTERIOR BOX ISOLATION DID NOT INCREASE THE INCIDENCE OF EDEL. IN PATIENTS DIAGNOSED WITH EDEL, MEAN CATHETER CONTACT FORCE DURING POSTERIOR WALL ABLATION WAS HIGHER (11.9 ± 1.8 VS. 14.7 ± 3 G, P < .001), MEAN RF DURATION WAS SHORTER (11.9 ± 1 VS. 10.7 ± 1.2 S, P < .001), WHILE ACHIEVED ABLATION INDEX WAS NOT DIFFERENT BETWEEN GROUPS (434 ± 4.9 VS. 433 ± 9.5, N.S.). CONCLUSION: INCIDENCE OF EDEL AFTER CLOSE-GUIDED-50 W-HPSD PVI IS LOWER COMPARED TO HISTORICAL COHORTS USING STANDARD-POWER RF SETTINGS. CATHETER CONTACT FORCE DURING POSTERIOR HPSD ABLATION SHOULD NOT EXCEED 15 G LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS THERMOCOOL SMARTTOUCH SF CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO, LASSO, SMART- ABLATE RF GENERATOR. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ABBOTT AGILIS MEDIUM CURVE SHEATHS AND AN ABBOTT BRK NEEDLE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF ABLATION CATHETER: QTY (B)(4) ¿ (ESOPHAGEAL ULCER) (RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593556 UNK_THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other ABBOTT AGILIS MEDIUM CURVE SHEATH| ABBOTT BRK NEEDLE| CARTO| LASSO| SMART- ABLATE RF GENERATOR