BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE

    MDR report key: 18699587 · Received February 13, 2024

    Report

    Report Number
    2029046-2024-00484
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    January 19, 2024
    Report Date
    February 13, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017076
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED SURGICAL INTERVENTION. 2 HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A TAMPONADE AT THE LEFT ATRIUM. A SURGICAL INTERVENTION WAS REQUIRED WITH THE IMPLANTATION OF A PATCH AT THE LEFT ATRIUM. TRANSSEPTAL PUNCTURE PERFORMED. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. THERE WAS NO STEAM POP. UNKNOWN AT WHAT PHASE THIS OCCURRED, THE TAMPONADE WAS DISCOVERED 2 HOURS AFTER THE PROCEDURE. LOCATION OF THE CARDIAC PERFORATION WAS AT THE FOOT OF THE AURICLE, AT THE LEVEL OF THE LEFT AURICLE, ABOVE THE MITRAL RING. THE PATIENT REQUIRED CARDIAC SURGERY. PATIENT HAS FULLY RECOVERED BUT REQUIRED EXTENDED HOSPITALIZATION AFTER SURGERY. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS PATIENT CONDITION. NO ERROR MESSAGES OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE. THE MOST SUSPECTED DEVICE IS THE ABLATION CATHETER AS IT IS UTILIZED TO DELIVER RF ENERGY VIA DIRECT CONTACT WITH CARDIAC TISSUE AND ABLATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81063 QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835017076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H BRAIDES TRANSSEPTAL GUILDING INTRODUCER| CARTO 3 SYSTEM WITH VISITAG| NGEN GENERATOR| PENTARAY NAV ECO| SL0 SWARTZ ABBOTT| WEBSTER CS CATHETER