BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 8445266 · Received March 22, 2019

    Report

    Report Number
    3002648230-2019-00219
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    February 22, 2019
    Report Date
    March 22, 2019
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE DATA FAILURE FILE SHOWED SYSTEM NOTICES (# (B)(4)) INDICATING THAT A LOW REFRIGERANT LEVEL, # (B)(4) ¿ TEMP IC INPUT¿, # (B)(4) ¿FLOW DIGITAL INPUT¿, AND FAILURE SYSTEM NOTICES (#(B)(4)) INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED, (# (B)(4)) INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED, (#(B)(4)) INDICATING THAT THE SYSTEM HAD AN ELECTRICAL COMPONENT FAILURE, (# (B)(4)) INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CONSOLE AND THE SYSTEM IN INOPERABLE, AND (# (B)(4)) INDICATING THAT THE SYSTEM DETECTED A SOFTWARE ERROR AND STOPPED THE INJECTION. IN CONCLUSION, A CLINICAL ISSUE (CARDIAC TAMPONADE, BLEEDING, HYPERTENSION) OCCURRED DURING THE CASE. THERE IS NO INDICATION OF RELA TION OF THE ADVERSE EVENT TO THE PERFORMANCE OF THE DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SUCCESSFUL CRYO ABLATION PROCEDURE, DURING POSTOPERATIVE HEMOSTATIC COMPRESSION, A DECREASE IN BLOOD PRESSURE WAS OBSERVED. ADDITIONALLY, A CARDIAC TAMPONADE WAS FOUND BY ULTRASOUND. NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237545 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 27821

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R 2AF283 BALLOON CATHETER