BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 5806690 · Received July 19, 2016

    Report

    Report Number
    9612164-2016-00690
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    June 23, 2016
    Report Date
    June 23, 2016
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DRF
    PMA / PMN Number
    D1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DATA FILES AND ACHIEVE CATHETER, 990063-020 WITH LOT NUMBER 2112037, WERE RETURNED AND ANALYZED. THE DATA FILES DID NOT SHOW ANY SYSTEM NOTICES OR ISSUES FOR THE DATE OF THE REPORTED EVENT. VISUAL INSPECTION OF THE CATHETER SHOWED THAT THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. A KNOWN CLINICAL ISSUE WAS ENCOUNTERED DURING THE PROCEDURE. IN CONCLUSION, THE ACHIEVE CATHETER, 990063-020 WITH LOT NUMBER 2112037, PASSED THE RETURNED PRODUCT INSPECTION AS PER SPECIFICATION.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO TARGET THE RIGHT INFERIOR PULMONARY VEIN (RIPV) A PROBABLE DISSECTION WAS OBSERVED AT THE OUTLINE OF THE LEFT ATRIUM NEAR THE RIPV. THE PROCEDURE WAS ABORTED; THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. THE PATIENT'S VITAL SIGNS WERE NOT IMPACTED AND A FULL RECOVERY WITHOUT EXTENDED HOSPITALIZATION WAS ACHIEVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456940 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC MEXICO 990063-020 211203713

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other