BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 6212641 · Received December 29, 2016

    Report

    Report Number
    3002648230-2016-00544
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    January 1, 2016
    Report Date
    November 30, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    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. 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 NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/53 YEARS OLD FOR THE PATIENTS REFERENCED IN THE ARTICLE. 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: ¿REPEAT PROCEDURES AFTER SECOND-GENERATION CRYOBALLOON ABLATION AS AN INDEX PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION: ONE-YEAR FOLLOW-UP.¿ J INTERV CARD ELECTROPHYSIOL (2016) 47:365¿371 DOI 10.1007/S10840-016-0179-5.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTS THE FOLLOWING PATIENT COMPLICATION WHILE USING A SHEATH CATHETER: THERE WAS ONE (1) PATIENT IN WHICH CARDIAC TAMPONADE OCCURRED AND SUBSEQUENT PERICARDIOCENTESIS WAS ¿SUCCESSFULLY PERFORMED.¿ 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
    863116 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R ACHIEVE MAPPING CATHETER