BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACHIEVE ADVANCE MAPPING CATHETER

    MDR report key: 8843900 · Received July 30, 2019

    Report

    Report Number
    2182208-2019-01380
    Event Type
    Death
    Date Received
    July 30, 2019
    Date of Event
    June 21, 2019
    Report Date
    August 27, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRF
    PMA / PMN Number
    K162892
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. THE DATA FILES SHOWED AT LEAST 16 APPLICATIONS WERE PERFORMED WITH BALLOON CATHETER 2AF284 WITH LOT 66715 WITHOUT ANY ISSUE ON THE DATE OF THE EVENT. DATA FILES NOT ABLE TO CONFIRM THE CLINICAL ISSUES. THE PHYSICAL PRODUCT WAS NOT RETURNED FOR INVESTIGATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DECEASED. THE PHYSICIAN ATTEMPTED A COUPLE OF FREEZES IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV) WITH NO GOOD OCCLUSION. THEN, THEY PROCEEDED TO THE RIGHT INFERIOR PULMONARY VEIN (RIPV) AND LATER RETURNED TO THE LSPV. HOWEVER, THERE WAS NO TIME TO ISOLATION (TTI). THEN, ANOTHER FREEZE WAS ATTEMPTED BUT THERE WAS A SUDDEN PRESSURE DROP. AN EFFUSION WAS NOTED AND A PERICARDIOCENTESIS WAS DONE. ADDITIONALLY, THERE WAS A PERFORATION IN THE LSPV. FURTHERMORE, THERE WAS A LOT OF BLOOD WHICH COULD NOT BE CONTAINED. THE PATIENT BLED OUT DUE TO A HOLE OR TEAR IN THE LSPV AND PASSED AWAY. THE CAUSE OF THE PERFORATION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633925 ACHIEVE ADVANCE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC, INC. 2ACH20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death