BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 5548593 · Received April 5, 2016

    Report

    Report Number
    3002648230-2016-00134
    Event Type
    Malfunction
    Date Received
    April 5, 2016
    Date of Event
    March 8, 2016
    Report Date
    March 8, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE, FLEXCATH ADVANCE SHEATH 4FC12 WITH LOT NUMBER 31822-70, AND DATA FILES WERE RETURNED. DATA FILES SHOW NO ISSUES DURING THE PROCEDURE. VISUAL INSPECTION OF THE SHEATH SHOWED THE SHAFT WAS INTACT WITH NO APPARENT ISSUES. AIR ASPIRATION WAS NOT REPRODUCED WHEN A TEST BALLOON CATHETER WAS INTRODUCED THROUGH THE SHEATH. DISSECTION REVEALED AN INTACT HEMOSTATIC VALVE. IN CONCLUSION, THE REPORTED ISSUE OF AIR ASPIRATION/INGRESS WAS NOT ABLE TO BE REPRODUCED. THE PRODUCT PASSED THE RETURNED PRODUCT INSPECTION.

    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.

    Additional Manufacturer Narrative · 1

    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 CRYO ABLATION PROCEDURE AIR BUBBLES WERE VISIBLE VIA THE TRANS ESOPHAGEAL ECHO (TEE) AFTER INSERTION OF THE SHEATH IN THE LEFT ATRIUM; ASSOCIATED ST SEGMENT ELEVATION ON ELECTROCARDIOGRAM (EKG) WAS ALSO OBSERVED. THE SHEATH WAS REPLACED. IT WAS ADDITIONALLY REPORTED THAT THE BALLOON CATHETER Y CONNECTOR PORT BROKE WHEN USING THE PUSH BUTTON. THIS OCCURRED AFTER THE AIR INGRESS AND THE BALLOON CATHETER WAS NOT INTRODUCED IN THE SHEATH WHEN AIR WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203246 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 31822

    Patients

    Seq Age Sex Outcome Treatment
    1 Other