BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 16678657 · Received April 4, 2023

    Report

    Report Number
    3002648230-2023-00157
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    December 10, 2022
    Report Date
    April 4, 2023
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER CHARACTERISTICS IS MALE. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: THE IMPORTANCE OF ANAESTHESIA IN ATRIAL FIBRILLATION ABLATION: COMPARING CONSCIOUS SEDATION WITH GENERAL ANAESTHESIA. INDIAN PACING AND ELECTROPHYSIOLOGY JOURNAL 23 (2023) 47-52. DOI: 10.1016/J.IPEJ.2022.12.001 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING CRYOBALLOON ABLATION. THE AUTHORS DESCRIBED PATIENTS WHO EXPERIENCED PROCEDURAL COMPLICATIONS, WHICH INCLUDED PERICARDIAL TAMPONADES, BOTH WERE TREATED WITH A SUBCOSTAL DRAIN, AND ONE TRANSIENT ISCHEMIC ATTACK (TIA). THERE WERE MINOR COMPLICATIONS WHICH INCLUDED GROIN HEMATOMAS, NEITHER REQUIRED AN INTERVENTION, TRANSIENT HEMOPTYSIS, AND TRANSIENT PHRENIC PALSIES. THE STATUS OF THE CATHETERS AND SHEATHS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441670 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| R