BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 5981050 · Received September 27, 2016

    Report

    Report Number
    3002648230-2016-00411
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    January 1, 2016
    Report Date
    August 31, 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

    CONCOMITANT PRODUCT: ACHIEVE MAPPING CATHETER. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THE 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 DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/58 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: ¿IMPROVED VISUALISATION OF REAL-TIME RECORDINGS DURING THIRD GENERATION CRYOBALLOON ABLATION: A COMPARISON BETWEEN THE NOVEL SHORT-TIP AND THE SECOND GENERATION DEVICE.¿ J INTERV CARD ELECTROPHYSIOL (2016) 46:307¿314. DOI 10.1007/S10840-016-0114-9.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTED THE FOLLOWING PATIENT COMPLICATION WHILE USING A SHEATH CATHETER: THERE WERE EIGHT (8) PATIENTS WHO HAD FEMORAL PSEUDO-ANEURYSMS WHICH REQUIRED INTERVENTION OR ¿PROLONGED¿ HOSPITAL STAYS. 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
    631062 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

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