BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 7452371 · Received April 23, 2018

    Report

    Report Number
    3002648230-2018-00247
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    January 1, 2018
    Report Date
    April 23, 2018
    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. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/66 YEARS OLD. MULTIPLE PATIENTS/MANUFACTURERS/METHODS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/PRODUCT SERIAL NUMBERS/COMPLAINTS. 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: LOW RISK OF PULMONARY VEIN STENOSIS AFTER CONTEMPORARY ATRIAL FIBRILLATION ABLATION LESSONS FROM REPEAT PROCEDURES AFTER RADIOFREQUENCY CURRENT, CRYOBALLOON, AND LASER BALLOON CIRC J DOI: 10.1253/CIRCJ.CJ-17-1324. 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 TWO (2) PATIENTS WHO EXPERIENCED PHRENIC NERVE PALSY (PNP) WITH UNKNOWN TREATMENT/RESOLUTION. THERE WAS ALSO ONE (1) PATIENT WITH A ¿GROIN-RELATED COMPLICATION,¿ WITH UNKNOWN TREATMENT RESOLUTION. THERE WERE 12 PATIENTS WHO SHOWED ¿MILD¿ PULMONARY VEIN STENOSIS; ALL OF WHICH DID NOT REQUIRE ANY INTERVENTION/SURGERY. OF NOTE, MULTIPLE PATIENTS/MANUFACTURERS/METHODS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/PRODUCT SERIAL NUMBERS/COMPLAINTS. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. THE STATUS/LOCATION OF THE SYSTEM 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
    293301 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC CRYOCATH LP 990063-015

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other ACHIEVE MAPPING CATHETER