BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 5461058 · Received February 25, 2016

    Report

    Report Number
    3002648230-2016-00064
    Event Type
    Injury
    Date Received
    February 25, 2016
    Date of Event
    December 23, 2015
    Report Date
    February 9, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE REFERENCED IN THE ARTICLE. THE BASELINE CHARACTERISTICS OF THE PATIENTS REFERENCED IN THE ARTICLE IS GENDER/AGE IS MALE/64 YEARS OLD. 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. REFERENCED ARTICLE: STRAUBE F, DORWARTH U, HARTL S, BUNZ B, WANKERL M, EBERSBERGER U, HOFFMANN E. ¿OUTCOME OF PAROXYSMAL ATRIAL FIBRILLATION ABLATION WITH THE CRYOBALLOON USING TWO DIFFERENT APPLICATION TIMES: THE 4- VERSUS 3-MIN PROTOCOL.¿ J INTERV CARD ELECTROPHYSIOL. DOI 10.1007/S10840-015-0084-3. (B)(4).

    Description of Event or Problem · 1

    STRAUBE F, DORWARTH U, HARTL S, BUNZ B, WANKERL M, EBERSBERGER U, HOFFMANN E. "OUTCOME OF PAROXYSMAL ATRIAL FIBRILLATION ABLATION WITH THE CRYOBALLOON USING TWO DIFFERENT APPLICATION TIMES: THE 4- VERSUS 3-MIN PROTOCOL." J INTERV CARD ELECTROPHYSIOL. DOI 10.1007/S10840-015-0084-3. THE LITERATURE PUBLICATION REPORTED THE FOLLOWING PATIENT COMPLICATIONS: TWO (2) PATIENTS DEVELOPED GROIN HEMATOMAS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118456 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR