BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 6818506 · Received August 24, 2017

    Report

    Report Number
    3002648230-2017-00462
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    July 25, 2017
    Report Date
    July 28, 2017
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    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 SIX INJECTIONS WERE PERFORMED WITH CATHETER 2AF284 / 12130-81 ON THE DATE OF THE EVENT WITHOUT ANY SYSTEM NOTICE. FAILURE FILE DID NOT SHOW ANY SYSTEM NOTICE TRIGGERED ON THE DATE OF THE EVENT. UPON VISUAL INSPECTION OF CATHETER 2AF284 / 12130-81, RESULTS SHOWED THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR SIX INJECTIONS. THE CATHETER PASSED THE PERFORMANCE TEST; ELECTRICAL INTEGRITY AND IMPEDANCE WERE ALSO WITHIN SPECIFICATION. THE OD OF THE BALLOON PROXIMAL BONDING WAS WITHIN SPECIFICATION 3.94MM. INSERTION AND RETRACTION TESTS WERE PERFORMED WITH NO ISSUES. DISSECTION / PRESSURE TESTING DID NOT SHOW ANY LEAKS OR TRACES OF LIQUID/BLOOD INSIDE THE CATHETER. IN CONCLUSION, THE CATHETER PASSED THE RETURNED PRODUCT INSPECTION AS PER SPECIFICATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER WAS INFLATED OUTSIDE OF THE PATIENT¿S BODY AND AIR WAS ASPIRATED. WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH, AIR WAS INTRODUCED AND ¿MORE RESISTANCE THAN USUAL¿ WAS OBSERVED. IT WAS NOTED THAT NEITHER THE BALLOON CATHETER NOR THE SHEATH WERE REPLACED. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598492 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 12130

    Patients

    Seq Age Sex Outcome Treatment
    1