BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER - 15 MM

    MDR report key: 8894698 · Received August 14, 2019

    Report

    Report Number
    3002648230-2019-00588
    Event Type
    Injury
    Date Received
    August 14, 2019
    Date of Event
    January 1, 2019
    Report Date
    August 14, 2019
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE OVERALL BASELINE GENDER/AGE CHARACTERISTICS IS MALE/65 YEARS OLD. 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿EFFICACY AND SAFETY OF CRYOBALLOON ABLATION IN PATIENTS WITH HEART FAILURE AND REDUCED LEFT VENTRICULAR EJECTION FRACTION. A MULTICENTER STUDY.¿ CIRCULATION JOURNAL. 2019; 83(8):1653-1659. DOI://10.1253/CIRCJ.CJ-19-0151. 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 COMPLICATIONS DURING THE USE OF A CRYOBALLOON ABLATION CATHETER SYSTEM: THERE WERE SIX (6) PATIENTS WHO EXPERIENCED PHRENIC NERVE PALSY (PNP); ALL OF WHICH RECOVERED WITHIN TWELVE MONTHS. THERE WERE TWO (2) PATIENTS WITH ¿SEVERE¿ GROIN HEMATOMAS; BOTH OF WHICH REQUIRED BLOOD TRANSFUSIONS, BUT NO SURGICAL INTERVENTION. THERE WAS ALSO ONE (1) PATIENT WHO EXPERIENCED A CARDIAC TAMPONADE WHICH RESOLVED AFTER DRAINAGE. 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 STATUS/DISPOSITION OF THE CRYOABLATION 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
    689273 ACHIEVE MAPPING CATHETER - 15 MM CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC CRYOCATH LP 990063-015

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R FLEXCATH ADVANCE STEERABLE SHEATH