BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 4130048 · Received September 30, 2014

    Report

    Report Number
    3002648230-2014-00160
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC CRYOCATH WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. PSEUDOANEURYSM IS LISTED IN THE PRODUCT LABELLING AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CANNULATION OF THE PERIPHERAL VASCULATURE AND INTRACARDIAC PLACEMENT OF THE SHEATH AND DILATOR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LITERATURE: GIOVANNI GDD, WAUTERS K, CHIERCHIA G-B, ET AL. ONE-YEAR FOLLOW-UP AFTER SINGLE PROCEDURE CRYOBALLOON ABLATION: A COMPARISON BETWEEN THE FIRST AND SECOND GENERATION BALLOON. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2014;25(8):834-839. THE SOURCE LITERATURE REPORTED THAT 1 PATIENT EXPERIENCED A FEMORAL PSEUDOANEURYSM THAT REQUIRED SURGICAL INTERVENTION FOR RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607248 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention