BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 20138110 · Received September 4, 2024

    Report

    Report Number
    3002648230-2024-00404
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 4, 2024
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID AFAPRO28 (37528); PRODUCT TYPE: ARCTIC FRONT CATHETER PRODUCT ID 2ACH20 (8812882); PRODUCT TYPE: ACHIEVE CATHETER. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TRANSSEPTAL PUNCTURE AND ISOLATION OF ALL FOUR PULMONARY VEINS WERE SUCCESSFUL. AT THE END OF THE CASE ANOTHER MANUFACTURER'S CATHETER WAS INSERTED LEFT ATRIUM. IT WAS OBSERVED THAT THE LEFT ATRIAL APPENDAGE (LAA) WAS PUNCTURED. THE PATIENT DEVELOPED LOW BLOOD PRESSURE, SINUS TACHYCARDIA AND CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED IMMEDIATELY, AND THE EXTRA FLUID WAS TAKEN FROM THE PERICARDIAL. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899109 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 0012076325

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Life Threatening| R