BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 5084277 · Received September 17, 2015

    Report

    Report Number
    3002648230-2015-00298
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE, FLEXCATH ADVANCE SHEATH 4FC12 WITH LOT NUMBER 39916-96, WAS RETURNED AND ANALYZED. VISUAL INSPECTION SHOWED THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. DEFLECTION WORKED AS PER SPECIFICATION. NO INDICATION OF A PRODUCT MALFUNCTION. THE DEVICE PASSED THE RETURNED PRODUCT INSPECTION AS PER SPECIFICATION. THIS WAS A KNOWN CLINICAL ISSUE ENCOUNTERED DURING THE PROCEDURE AND NO PRODUCT MALFUNCTION WAS REPORTED OR INDICATED UPON ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE WHILE EXCHANGING THE TRANSSEPTAL SHEATH TO THE ACCESS SHEATH, THE SUPERFICIAL FEMORAL VEIN WAS PERFORATED BY THE ACCESS SHEATH. ADDITIONALLY, IT WAS REPORTED THAT WHEN THE VESSEL WAS ACCESSED IT WAS PUNCTURED. THE ACCESS DEVICE WAS REMOVED AND THE VESSEL WAS PUNCTURED AGAIN. PERFORATION WAS ATTRIBUTED TO POOR VESSEL ACCESS BY THE PHYSICIAN. THE PROCEDURE WAS ABORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616391 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 39916

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention