BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 7176745 · Received January 9, 2018

    Report

    Report Number
    3002648230-2018-00037
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    December 14, 2017
    Report Date
    February 15, 2018
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE PATIENT DATA FILES SHOWED AT LEAST NINE APPLICATIONS WERE PERFORMED WITH CATHETER 2AF284 / 85145-63 WITHOUT ANY ISSUES OR SYSTEM NOTICES ON THE DATE OF EVENT. THE DATA FILES CONFIRMED SYSTEM NOTICES (#50012) WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED AT APPLICATION #12 AND SYSTEM NOTICE (#50011) INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED AT APPLICATIONS #13 AND #14 FOR CATHETER 239F3 / 15994-84 ON THE DATE OF EVENT. THE PATIENT DATA FILES ALSO SHOWED AT LEAST FIVE APPLICATIONS WERE PERFORMED WITH THIS CATHETER. THE DATA BIN FILES ALSO SHOWED FOUR APPLICATIONS WERE PERFORMED WITH CATHETER 23935/89450-12 WITHOUT ANY ISSUES OR SYSTEM NOTICES ON THE DATE OF EVENT. THE CLINICAL ISSUE MENTIONED IN THE EVENT CANNOT BE CONFIRMED THROUGH DATA ANALYSIS. IN CONCLUSION, THE REPORTED ¿SYSTEM NOTICES #50011 AND #50012¿ ISSUES WERE CONFIRMED THROUGH DATA ANALYSIS. THE REPORTED ¿SYSTEM NOTICES #50011 WAS CONFIRMED THROUGH TESTING. THE SHEATH 4FC12 / 07516 WAS NOT RETURNED FOR INVESTIGATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    (B)(6) 2017, 10:34:44: NEW INCOMING INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD A PSEUDOANEURYSM,AS OBSERVED VIA COMPUTED TOMOGRAPHY (CT) SCAN. THE SURGICAL PROCEDURE WAS COMPLETED ON THAT SAME DAY, AND THE PATIENT'S HOSPITALIZATION WAS EXTENDED. THE PATIENT IS PART OF THE STOP PERSISTENT AF CLINICAL STUDY. (B)(6) 2018: ADDITIONAL INFORMATION FURTHER REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AN UNKNOWN SYSTEM NOTICE WAS RECEIVED INDICATING A "COOLANT ROUTE" ERROR. THE CABLES WERE REPLACED WITHOUT RESOLVE. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS THEN REPLACED, AND THE CASE WAS COMPLETED WITH CRYO. ALSO. POST PROCEDURE, THERE WAS NO ABNORMALITIES IN THE WOUND. THERE WAS NO ISSUE WITH THE PATIENT STATUS. THE PATIENT WAS DISCHARGED UNDER REMISSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A CRYO ABLATION PROCEDURE, THE PATIENT HAD A PSEUDOANEURYSM, AS OBSERVED ON A COMPUTED TOMOGRAPHY (CT) SCAN. SURGICAL PROCEDURE WAS COMPLETED ON THAT SAME DAY, AND THE PATIENT'S HOSPITALIZATION WAS EXTENDED. THE PATIENT IS PART OF THE STOP PERSISTENT AF CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18183 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 07516

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R