BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 20093267 · Received August 29, 2024

    Report

    Report Number
    2029046-2024-02881
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    June 22, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YAMADA T. REFRIGERATED COLD SALINE VERSUS AMBIENT-TEMPERATURE SALINE IRRIGATION DURING RADIOFREQUENCY CATHETER ABLATION OF ATRIAL FIBRILLATION. J INTERV CARD ELECTROPHYSIOL. 2024 JUN 22. DOI: 10.1007/S10840-024-01851-6. EPUB AHEAD OF PRINT. PMID: 38907074. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YAMADA T. REFRIGERATED COLD SALINE VERSUS AMBIENT-TEMPERATURE SALINE IRRIGATION DURING RADIOFREQUENCY CATHETER ABLATION OF ATRIAL FIBRILLATION. J INTERV CARD ELECTROPHYSIOL. 2024 JUN 22. DOI: 10.1007/S10840-024-01851-6. EPUB AHEAD OF PRINT. PMID: 38907074. OBJECTIVE/METHODS/STUDY DATA: THE STUDY SOUGHT TO COMPARE THE EFFECT OF REFRIGERATED COLD SALINE (RCS) IRRIGATION ON THE OUTCOMES OF RADIOFREQUENCY (RF) CATHETER ABLATION OF ATRIAL FIBRILLATION (AF) WITH THAT OF CONVENTIONAL AMBIENT-TEMPERATURE SALINE (ATS) IRRIGATION. DURING THE STUDY, A TOTAL OF 40 PATIENTS (26 MALE AND 14 FEMALE) WITH A MEAN AGE OF 65 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS HAD SYMPTOMATIC DRUG-REFRACTORY ATRIAL FIBRILLATION WHO UNDERWENT PULMONARY VEIN ISOLATION (PVI) USING AN IRRIGATED TIP ABLATION CATHETER THERMOCOOL SMARTTOUCH (BIOSENSE WEBSTER). THE PATIENTS WERE GROUPED INTO RCS AND ATS IRRIGATIONS. IN THE FIRST 20 PATIENTS, RCS WAS INADVERTENTLY USED AND WAS REPLACED BY ATS IN THE SECOND 20 PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH ABLATION CATHETER ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH THERMOCOOL SMARTTOUCH (QTY 4): - 4 PATIENTS HAD POSTPROCEDURAL PERICARDITIS WITH NO INTERVENTION REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179416 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other