BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 20083100 · Received August 28, 2024

    Report

    Report Number
    2029046-2024-02857
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    May 21, 2024
    Report Date
    August 27, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: TROISI F, VALENTI N, QUADRINI F, VITULANO N, DI MONACO A, ROMANAZZI I, CARUSO R, ORFINO R, GRIMALDI M. ZERO-FLUOROSCOPY CATHETER ABLATION OF RIGHT APPENDAGE FOCAL ATRIAL TACHYCARDIA IN A PREGNANT WOMAN. CLIN PRACT. 2024 MAY 21;14(3):946-953. DOI: 10.3390/CLINPRACT14030075. PMID: 38804407; PMCID: PMC11130856. 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).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TROISI F, VALENTI N, QUADRINI F, VITULANO N, DI MONACO A, ROMANAZZI I, CARUSO R, ORFINO R, GRIMALDI M. ZERO-FLUOROSCOPY CATHETER ABLATION OF RIGHT APPENDAGE FOCAL ATRIAL TACHYCARDIA IN A PREGNANT WOMAN. CLIN PRACT. 2024 MAY 21;14(3):946-953. DOI: 10.3390/CLINPRACT14030075. PMID: 38804407; PMCID: PMC11130856. OBJECTIVE/METHODS/STUDY DATA: THIS CASE REPORT, DESCRIBED A COMPLEX CLINICAL CASE OF A 34-YEAR-OLD PREGNANT WOMAN WHO WAS AFFECTED BY AN INCESSANT RIGHT ATRIAL TACHYCARDIA, WITH SIGNS AND SYMPTOMS OF INITIAL HEMODYNAMIC INSTABILITY. AN OCTARAY MAPPING CATHETER (BIOSENSE WEBSTER) HIGHLIGHTED A FOCAL RIGHT ATRIAL TACHYCARDIA WITH EVIDENCE OF MAXIMUM PRECOCIOUSNESS IN THE RIGHT APPENDAGE; AND A Q-DOT ABLATION CATHETER (BIOSENSE WEBSTER) WAS USED WITH A MAXIMUM POWER OF 40 WATTS WERE USED DURING THE FIRST PROCEDURE AND WAS STOPPED HALFWAY DUE TO PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. A HEMODYNAMIC STABILIZATION AND A GYNECOLOGICAL CONSULTATION WAS DONE AND IN THE FOLLOWING DAYS THE PATIENT UNDERWENT ANOTHER CATHETER ABLATION PROCEDURE. THIS TIME A "ZERO-FLUOROSCOPY" ABLATION TECHNIQUE WAS USED BASED ON THREE-DIMENSIONAL MAPPING SYSTEMS AND INTRACARDIAC ULTRASOUND IS INCREASINGLY EXPANDING IN THE ELECTROPHYSIOLOGICAL FIELD. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: Q-DOT MICRO CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: OCTARAY MAPPING CATHETER. A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE COMPLICATION DURING THE FIRST PROCEDURE WERE MANAGED WITH PERICARDIOCENTESIS, HEMODYNAMIC STABILIZATION AND A GYNECOLOGICAL CONSULTATION WERE REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED Q-DOT MICRO CATHETER. QTY 1: PERICARDIAL EFFUSION AND CARDIAC TAMPONADE MANAGED WITH PERICARDIOCENTESIS, HEMODYNAMIC STABILIZATION AND A GYNECOLOGICAL CONSULTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198270 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L UNK_OCTARAY NAV