BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 5968159 · Received September 21, 2016

    Report

    Report Number
    3002648230-2016-00398
    Event Type
    Injury
    Date Received
    September 21, 2016
    Date of Event
    January 1, 2012
    Report Date
    August 25, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: CRYOCONSOLE 106E2. 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 U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/(B)(6) YEARS OLD FOR THE PATIENTS REFERENCED IN THE ARTICLE. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. 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: ¿ADENOSINE TESTING AFTER CRYOBALLOON PULMONARY VEIN ISOLATION IMPROVES LONG-TERM CLINICAL OUTCOME.¿ NETH HEART J (2012) 20:447¿455. DOI 10.1007/S12471-012-0319-1.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    Y. L. E. VAN BELLE <(>&<)> P. A. JANSE <(>&<)> N. M. S DE GROOT <(>&<)> W. ANNÉ <(>&<)> D. A. M. J. THEUNS <(>&<)> L. J. JORDAENS. ¿ADENOSINE TESTING AFTER CRYOBALLOON PULMONARY VEIN ISOLATION IMPROVES LONG-TERM CLINICAL OUTCOME.¿ NETH HEART J (2012) 20:447¿455. DOI 10.1007/S12471-012-0319-1. THE LITERATURE PUBLICATION REPORTS THE FOLLOWING PATIENT COMPLICATION: THERE WAS ONE (1) PATIENT WHO HAD A PERICARDIAL TAMPONADE WHICH WAS DRAINED. THE STATUS/LOCATION OF THE SHEATH 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
    618950 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R ARCTIC FRONT CARDIAC CRYOABLATION CATHETER