BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 6169290 · Received December 13, 2016

    Report

    Report Number
    3002648230-2016-00523
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    January 1, 2016
    Report Date
    November 15, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER. MEDTRONIC CRYOCATH 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. 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/(B)(6) 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: ¿PREVALENCE AND PRE-PROCEDURAL PREDICTORS ASSOCIATED WITH RIGHT PHRENIC NERVE INJURY IN ELECTROMYOGRAPHY-GUIDED, SECOND-GENERATION CRYOBALLOON ABLATION: SINGLE LARGE BALLOON AND SINGLE 3-MINUTE FREEZE TECHNIQUES.¿ JACC CLIN ELECTROPHYSIOL. 2016;2(4):508-514.

    Additional Manufacturer Narrative · 1

    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 COMPLICATION WHILE USING A MAPPING CATHETER: THERE WAS ONE (1) PATIENT WITH PNEUMOTHORAX DURING THE PUNCTURE OF THE RIGHT SUBCLAVIAN VEIN. THE STATUS/LOCATION OF THE MAPPING CATHETER 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
    821770 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC CRYOCATH LP 990063-020

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R FLEXCATH ADVANCE STEERABLE SHEATH