BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 3290555 · Received August 15, 2013

    Report

    Report Number
    3007798852-2013-00012
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 6, 2013
    Manufacturer
    MEDTRONIC ABLATION FRONTIERS
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC CRYOCATH WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THERE WAS NO INDICATION IN THE LITERATURE PUBLICATION OF PRODUCT MALFUNCTION. THE ACTUAL DATE OF EVENT WAS NOT PROVIDED. THE EVENT DATE REPORTED IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC CRYOCATH WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE. PUBLICATION REFERENCE: CONTE G, CHIERCHIA GB, CASADO-ARROYO R, ILSEN B, BRUGADA P. PULMONARY VEIN INTRAMURAL HEMATOMA AS A COMPLICATION OF CRYOBALLOON ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. JULY 1 2013;24(7):830-831. IT WAS REPORTED IN THE ABOVE-REFERENCED LITERATURE PUBLICATION THAT THERE WAS TRAUMA OF THE WALL OF THE PULMONARY VEIN BECAUSE OF A SMALL VENOUS DISSECTION DURING MAPPING CATHETER INSERTION. PATIENT EXPERIENCED HEMOPTYSIS AND TREATMENT INCLUDED TEMPORARY INTERRUPTION OF HEPARIN THERAPY. TWO MONTH FOLLOW-UP WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394697 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC ABLATION FRONTIERS 990063-020

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization ARCTIC FRONT CARDIAC CRYOABLATION CATHETER, 2AF281