BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 14701850 · Received June 15, 2022

    Report

    Report Number
    2029046-2022-01324
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    December 13, 2021
    Report Date
    June 15, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. LITERATURE CITATION: JURCEVIC R, ANGELKOV L, TASIC N, TOMOVIC M, KOJIC D, OTASEVIC P, BOJIC M. PULMONARY VEIN ISOLATION OUTCOME DEGREE IS A NEW SCORE FOR EFFICACY OF ATRIAL FIBRILLATION CATHETER ABLATION. J CLIN MED. 2021 DEC 13;10(24):5827. DOI: 10.3390/JCM10245827. PMID: 34945124; PMCID: PMC8708501. 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. THE LITERATURE FILE IS TOO LARGE TO ATTACH. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. LITERATURE CITATION: JURCEVIC R, ANGELKOV L, TASIC N, TOMOVIC M, KOJIC D, OTASEVIC P, BOJIC M. PULMONARY VEIN ISOLATION OUTCOME DEGREE IS A NEW SCORE FOR EFFICACY OF ATRIAL FIBRILLATION CATHETER ABLATION. J CLIN MED. 2021 DEC 13;10(24):5827. DOI: 10.3390/JCM10245827. PMID: 34945124; PMCID: PMC8708501. OBJECTIVE/METHODS/STUDY DATA: AUTHORS' STUDY AIMED TO EVALUATE PULMONARY VEIN ISOLATION OUTCOME DEGREE (PVIOD) AS A NEW SEMIQUANTITATIVE MEASURE FOR PVI SUCCESS AFTER A 7-YEAR FOLLOW-UP AND TO DETERMINE PARAMETERS FOR PREDICTING THE PVIOD. THIS PROSPECTIVE STUDY INCLUDED 124 CONSECUTIVE PATIENTS WITH SYMPTOMATIC AF WHO UNDERWENT PVI FROM JANUARY 2012 TO DECEMBER 2013. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: NAVISTAR THERMOCOOL CONCOMITANT OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: PENTARAY CATHETER, CARTO3. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH ABLATION CATHETER: QTY 1 RUPTURE OF MITRAL VALVE CHORDAE TREATED WITH OPEN HEART SURGERY AND MITRAL VALVULOPLASTY. QTY 2 CARDIAC TAMPONADES TREATED WITH PERICARDIOCENTESIS . QTY 1 PNEUMOTHORAX RESOLVING WITH PLEURAL DRAINAGE. QTY 1 STROKE(CVA) - INTERVENTION NOT DISCUSSED BUT CONSIDERED A MAJOR COMPLICATION. QTY 5 PERICARDIAL EFFUSION MANAGED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208201 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R UNK_CARTO 3| UNK_PENTARAY