BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 7359762 · Received March 21, 2018

    Report

    Report Number
    3002648230-2018-00174
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    April 10, 2017
    Report Date
    March 21, 2018
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER. MEDTRONIC 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. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS 68 YEARS OLD. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT NUMBERS. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, 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: EFFICACY AND SAFETY OF THE SECOND GENERATION CRYOBALLOON ABLATION FOR THE TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION IN PATIENTS OVER 75 YEARS: A COMPARISON WITH A YOUNGER COHORT. EUROPACE (2017) 19, 1798¿1803. DOI:10.1093/EUROPACE/EUX023. 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 COMPLICATIONS WHILE USING A CRYOABLATION BALLOON CATHETER SYSTEM: THERE WERE ELEVEN (11) PATIENTS WHO EXPERIENCED PERSISTENT OR TRANSIENT PHRENIC NERVE PALSY (PNP), WITH UNKNOWN TREATMENT/RESOLUTION. THERE WAS ONE (1) PATIENT WITH A GROIN HEMATOMA WHICH DID NOT REQUIRE ANY INTERVENTION, AND ONE (1) PATIENT WITH A FEMORAL PSEUDOANEURYSM THAT REQUIRED INTERVENTION VIA THROMBIN INJECTION. THE STATUS/LOCATION OF THE CRYOBALLOON CATHETER SYSTEM IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202613 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R