BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER CS CATHETER

    MDR report key: 16932673 · Received May 15, 2023

    Report

    Report Number
    2029046-2023-01026
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    April 13, 2023
    Report Date
    May 15, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835002423
    PMA / PMN Number
    K090898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS 2 REPORTS. 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 A PVI AND CTI ABLATION PROCEDURE WITH AN UNKNOWN SMART TOUCH BIDIRECTIONAL SF. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT ATRIAL FIBRILLATION AND TYPICAL FLUTTER WERE TREATED. A CS (CORONARY SINUS) BIDIRECTIONAL, LASSO NAV AND STSF WERE USED DURING THE PROCEDURE. THE PATIENT WAS SUCCESSFULLY ABLATED AND TRANSFERRED TO SINUS RHYTHM. AN ECHO WAS TAKEN AFTER THE PROCEDURE WITH NO COMPLICATIONS. 2 HOURS AFTER THE PROCEDURE, THE PATIENT'S PRESSURE DROPPED, SO SHE HAD TO GO BACK TO THE LAB. A PERICARDIAL EFFUSION WAS DIAGNOSED AND 1.6L BLOOD WAS TAKEN. THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER HOSPITAL. A SURGICAL PROCEDURE WAS PERFORMED. THE DOCTOR SUSPECTS THAT THE PERICARDIAL EFFUSION (PE) WAS CAUSED BY THE CS. THE PROCEDURE DATE AND EVENT DATE WAS (B)(6) 2023, 16:00. THE NAME OF THE PROCEDURE PERFORMED WAS PVI (PULMONARY VEIN ISOLATION) AND CTI (CAVOTRICUSPID ISTHMUS) ABLATION, BECAUSE OF AFIB AND TYPICAL FLUTTER. THE PRODUCT NUMBER OF THE CS CATHETER IS 36G5JMCT. DON¿T HAVE A PICTURE OF THE LABEL, BECAUSE THE CATHETER WAS DISCARDED AFTER THE PROCEDURE. IT WILL NOT BE POSSIBLE TO OBTAIN THE LOT NUMBER FOR THE REPORTED DEVICE. THE TYPE OF INTERVENTION USED AFTER THE EVENT REPORTED WAS ECHOCARDIOGRAM AND SURGICAL INTERVENTION. PERICARDIAL EFFUSION WAS DIAGNOSED VIA ECHOCARDIOGRAM, BECAUSE OF LOSING BLOOD PRESSURE, 2H POSTOP. BECAUSE OF THE PHYSICIAN'S OPINION COMBINED WITH THE COMPLEXITY OF THE CORONARY SINUS CAVITY, THE CORONARY SINUS DIAGNOSTIC CATHETER IS BEING CAPTURED AS AN ADDITIONAL SUSPECTED DEVICE AS A CONSERVATIVE APPROACH. THE UNIDENTIFIED STSF CATHETER CANNOT BE DISASSOCIATED FROM THE EVENT AS IT IS THE MOST SUSPECTED DEVICE DUE TO PROVIDING RF ENERGY IN DIRECT CONTACT WITH CARDIAC TISSUE. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351298 WEBSTER CS CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER INC BD710FJ282CT 10846835002423

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R LASSO NAV CATHETER