BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_THERMOCOOL SF NAV

    MDR report key: 23203077 · Received October 2, 2025

    Report

    Report Number
    2029046-2025-03336
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 6, 2025
    Report Date
    October 2, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SHIRAI Y, SHIOHIRA S, SASAKI T, KASAI Y, KITAI T, KAMATA T, KAWABATA M, OKISHIGE K, SASANO T, HIRAO K. CORONARY VENOUS OCCLUSION BY PRIOR CATHETER ABLATION WITHIN THE CORONARY VENOUS SYSTEM: A POTENTIAL RISK OF PRECLUDING BRANCH MAPPING AND ADJUNCTIVE CHEMICAL ABLATION. J INTERV CARD ELECTROPHYSIOL. 2025 SEP;68(6):1151-1157. DOI: 10.1007/S10840-025-02107-7. EPUB 2025 AUG 6. PMID: 40767906. 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: SHIRAI Y, SHIOHIRA S, SASAKI T, KASAI Y, KITAI T, KAMATA T, KAWABATA M, OKISHIGE K, SASANO T, HIRAO K. CORONARY VENOUS OCCLUSION BY PRIOR CATHETER ABLATION WITHIN THE CORONARY VENOUS SYSTEM: A POTENTIAL RISK OF PRECLUDING BRANCH MAPPING AND ADJUNCTIVE CHEMICAL ABLATION. J INTERV CARD ELECTROPHYSIOL. 2025 SEP;68(6):1151-1157. DOI: 10.1007/S10840-025-02107-7. EPUB 2025 AUG 6. PMID: 40767906. BACKGROUND: THIS CASE SERIES HIGHLIGHTS INSTANCES OF CORONARY VEIN OCCLUSION RESULTING FROM PRIOR RADIOFREQUENCY (RF) ABLATION WITHIN THE CORONARY VENOUS SYSTEM (CVS). IN CASE 2, ETHANOL INFUSION TO THE SEPTAL PERFORATOR WAS UNSUCCESSFUL DUE TO CVS OCCLUSION AT THE SITE OF PREVIOUS RF ENERGY DELIVERY. THESE CASES UNDERSCORE POTENTIAL CHALLENGES IN THE WORKFLOW OF ABLATION THERAPY FOR EPICARDIAL AND INTRAMURAL VENTRICULAR ARRHYTHMIAS, RAISING IMPORTANT CONSIDERATIONS FOR PROCEDURAL PLANNING AND MANAGEMENT. OBJECTIVE: TO EVALUATE THE IMPACT OF RADIOFREQUENCY (RF) ENERGY APPLICATIONS WITHIN THE CORONARY VENOUS SYSTEM (CVS) ON SUBSEQUENT PROCEDURES, WITH A FOCUS ON THE IMPORTANCE OF PRIORITIZING MAPPING AND ADJUNCTIVE CHEMICAL ABLATION FOR SMALL BRANCHES, AND TO REPORT A CASE SERIES OF CORONARY VENOUS OCCLUSION CAUSED BY PRIOR CATHETER ABLATION WITHIN THE CVS. METHODS: HOLTER MONITORING REVEALED 38% OF THE PVC/ NSVT BURDEN DESPITE PRIOR CATHETER ABLATION IN WHICH THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AND THE LVOT WERE TARGETED USING AN IRRIGATED TIP CATHETER (THERMOCOOL; BIOSENSE WEBSTER, DIAMOND BAR, CA, USA) RESULTING IN TRANSIENT SUPPRESSION AT BOTH SITES. CONCLUSIONS: THIS CASE ILLUSTRATES THAT CORONARY VENOUS OCCLUSION CAN OCCUR FOLLOWING PRIOR RF ABLATION, WHICH MAY HINDER SUBSEQUENT CHEMICAL AND RF ABLATION EFFORTS. DESPITE THE ABSENCE OF SYMPTOMS, SUCH OCCLUSIONS POSE SIGNIFICANT CHALLENGES IN THE MANAGEMENT OF VENTRICULAR ARRHYTHMIAS, EMPHASIZING THE NEED FOR CAREFUL PROCEDURAL PLANNING AND CONSIDERATION OF ALTERNATIVE STRATEGIES WHEN INITIAL ABLATION ATTEMPTS ARE UNSUCCESSFUL. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS:USING AN IRRIGATED TIP CATHETER (THERMOCOOL; BIOSENSE WEBSTER, DIAMOND BAR, CA, USA) OTHER BWI PRODUCTS: NONE. NON-BWI DEVICES: NONE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 54-YEAR-OLD MALE, AT THE REDO PROCEDURE, ETHANOL INFUSION TO THE SEPTAL PERFORATOR IDENTIFIED DURING THE FIRST PROCEDURE, WHICH WAS DISTRIBUTED OVER THE AREA OF INTEREST, WAS PLANNED. HOWEVER, A CORONARY VENOGRAM REVEALED AN OCCLUSION AT THE DISTAL GREAT CARDIAC VEIN (GCV) LEVEL, AND CHEMICAL ABLATION TO THE TARGETED BRANCH WAS ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313224 UNK_THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening