BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 6707842 · Received July 12, 2017

    Report

    Report Number
    3002648230-2017-00350
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    January 1, 2016
    Report Date
    August 23, 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

    CONCOMITANT MEDICAL PRODUCTS: ACHIEVE MAPPING CATHETER. MEDTRONIC CRYOCATH 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 CHARACTERISTIC IS MALE/61 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: ¿BONUS-FREEZE: BENEFIT OR RISK? TWO-YEAR OUTCOME AND PROCEDURAL COMPARISON OF A ¿¿BONUS-FREEZE¿¿ AND ¿¿NO BONUS-FREEZE¿¿ PROTOCOL USING THE SECOND-GENERATION CRYOBALLOON FOR PULMONARY VEIN ISOLATION.¿ CLIN RES CARDIOL (2016) 105:774¿782. DOI 10.1007/S00392-016-0987-8.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTS THE FOLLOWING PATIENT COMPLICATION WHILE USING A SHEATH CATHETER: THERE WAS ONE (1) PATIENT WITH CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. THE STATUS/LOCATION OF THE SHEATH 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
    485552 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER