BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECANAV

    MDR report key: 19879388 · Received July 31, 2024

    Report

    Report Number
    2029046-2024-02567
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 4, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    PMA / PMN Number
    K080425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    DURING MAPPING OF LEFT VENTRICLE, THE DECANAV CATHETER MOVED SIGNIFICANTLY ON THE 3D SCREEN AND WAS OBSERVED POPPING OUT OF THE LEFT VENTRICULAR FAM (FAST ANATOMICAL MAP). AFTER THAT, CARDIAC TAMPONADE WAS CONFIRMED DUE TO BLOOD PRESSURE DECREASE (BLOOD PRESSURE DROPPED TO ABOUT 50). PERICARDIAL FLUID DRAINAGE WAS PERFORMED. THE PATIENT'S SYMPTOMS WORSENED. AFTER DRAINAGE, OPEN CHEST SURGERY WAS PERFORMED AND ADDITIONAL CRYOABLATION WAS PERFORMED. THE PATIENT WAS ON ECMO BUT A VALVE WAS NOT WORKING, HEART WAS NOT MOVING WELL. THE PATIENT HAD PLANS FOR IMPELLA IN THE FUTURE. HOSPITALIZATION WAS EXTENDED. DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. MRE REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31219269M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A DECANAV AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. DURING MAPPING OF LEFT VENTRICLE, THE DECANAV CATHETER MOVED SIGNIFICANTLY ON THE 3D SCREEN AND WAS OBSERVED POPPING OUT OF THE LEFT VENTRICULAR FAM (FAST ANATOMICAL MAP). AFTER THAT, CARDIAC TAMPONADE WAS CONFIRMED DUE TO BLOOD PRESSURE DECREASE (BLOOD PRESSURE DROPPED TO ABOUT 50). PERICARDIAL FLUID DRAINAGE WAS PERFORMED. THE PATIENT'S SYMPTOMS WORSENED. AFTER DRAINAGE, OPEN CHEST SURGERY WAS PERFORMED AND ADDITIONAL CRYOABLATION WAS PERFORMED. THE PATIENT WAS ON ECMO BUT A VALVE WAS NOT WORKING, HEART WAS NOT MOVING WELL. THE PATIENT HAD PLANS FOR IMPELLA IN THE FUTURE. HOSPITALIZATION WAS EXTENDED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS THE PROCEDURE. THERE WERE NO ABNORMALITIES THAT OCCURRED PRIOR TO OR DURING USE OF THE PRODUCT. NO ABLATION WAS PERFORMED PRIOR TO NOTING THE CARDIAC TAMPONADE. TRANSSEPTAL PUNCTURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733130 DECANAV CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31219269M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R 7FR DECAN,11P,F,2.4MMLE,282MM,| 8.5F SHEATH WITH CURVE VIZ LGC| OPTRELL, 36 ELECTRODES, D-F| QDOT MICRO, BI, TC, D-F| SOUNDSTAR ECO GE 8F CATHETER| UNKNOWN GENERATOR| UNKNOWN MAPPING SYSTEM| UNKNOWN RF NEEDLE