BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 6870657 · Received September 15, 2017

    Report

    Report Number
    3002648230-2017-00515
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    January 1, 2017
    Report Date
    August 22, 2017
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC PATIENT OR DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT NUMBERS. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/62 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE, 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. REFERENCED ARTICLE: ¿CRYOBALLOON ABLATION OF PERSISTENT ATRIAL FIBRILLATION: FEASIBILITY AND SAFETY OF LEFT ATRIAL ROOF ABLATION WITH GENERATION OF CONDUCTION BLOCK IN ADDITION TO ANTRAL PULMONARY VEIN ISOLATION.¿ EUROPACE (2017) 19, 1109¿1115. DOI:10.1093/EUROPACE/EUW146. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTED THE FOLLOWING PATIENT COMPLICATION WHILE USING A SHEATH CATHETER: THERE WAS ONE (1) PATIENT WHO EXPERIENCED A ¿POST-PROCEDURE¿ FEMORAL ARTERY HEMATOMA WITH PSEUDOANEURYSM, WHICH REQUIRED SURGICAL TREATMENT (WHICH WAS ¿SUCCESSFUL¿). THE STATUS/LOCATION OF THE SHEATH CATHETER IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647749 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention