BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 7635361 · Received June 25, 2018

    Report

    Report Number
    3002648230-2018-00422
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    March 27, 2018
    Report Date
    June 26, 2018
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE PATIENT DATA FILES SHOWED AT LEAST ONE APPLICATION WAS PERFORMED WITH CATHETER 2AF284/90108 AND FOURTEEN APPLICATIONS PERFORMED 2AF284/40743 ON THE DATE OF THE EVENT, WITHOUT ANY SYSTEM NOTICES. FAILURE FILE CONFIRMED SYSTEM NOTICE (#50005) ¿THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION¿ AND SOME OTHER SYSTEM NOTICES ALSO TRIGGERED FOR THE DATE OF THE EVENT : EX: (#50011) ¿THE REFRIGERANT DELIVERY PATH IS OBSTRUCTED,¿ (#50012) ¿THE REFRIGERANT DELIVERY PATH IS OBSTRUCTED¿, AND (#50008) ¿THE SYSTEM HAS DETECTED A SOFTWARE ERROR AND STOPPED THE INJECTION¿. VISUAL INSPECTION OF CATHETER 2AF284/90108 SHOWED THE CATHETER WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR FIVE INJECTIONS. SYSTEM NOTICE #50005 IMMEDIATELY APPEARED UPON CONNECTING THE CATHETER TO THE CONSOLE OUTSIDE THE WATER BATH. DISSECTION SHOWED A GUIDE WIRE LUMEN KINK AND BREACH AT 0.99 INCHES FROM THE TIP INSIDE THE BALLOONS. IN CONCLUSION, THE REPORTED SYSTEM NOTICE (# 50005) WAS RECEIVED INDICATING THAT ¿THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION¿ WAS CONFIRMED THROUGH DATA ANALYSIS AND TESTING. THE BALLOON CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO GUIDEWIRE LUMEN BREACH AND KINK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE PATIENT DATA FILES SHOWED AT LEAST ONE APPLICATION WAS PERFORMED WITH CATHETER 2AF284/90108-19 AND FOURTEEN APPLICATIONS PERFORMED 2AF284/40743-60 ON THE DATE OF THE EVENT, WITHOUT ANY SYSTEM NOTICES. FAILURE FILE CONFIRMED SYSTEM NOTICE (#(B)(4)) ¿THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION¿ AND SOME OTHER SYSTEM NOTICES ALSO TRIGGERED FOR THE DATE OF THE EVENT : EX: (#(B)(4)) ¿THE REFRIGERANT DELIVERY PATH IS OBSTRUCTED,¿ (#(B)(4)) ¿THE REFRIGERANT DELIVERY PATH IS OBSTRUCTED¿, AND (B)(4)) ¿THE SYSTEM HAS DETECTED A SOFTWARE ERROR AND STOPPED THE INJECTION¿. VISUAL INSPECTION OF CATHETER 2AF284/90108-19 SHOWED THE CATHETER WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR FIVE INJECTIONS. SYSTEM NOTICE # (B)(4) IMMEDIATELY APPEARED UPON CONNECTING THE CATHETER TO THE CONSOLE OUTSIDE THE WATER BATH. DISSECTION SHOWED A GUIDE WIRE LUMEN KINK AND BREACH AT 0.99 INCHES FROM THE TIP INSIDE THE BALLOONS. IN CONCLUSION, THE REPORTED SYSTEM NOTICE (# (B)(4)) WAS RECEIVED INDICATING THAT ¿THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION¿ WAS CONFIRMED THROUGH DATA ANALYSIS AND TESTING. THE BALLOON CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO GUIDEWIRE LUMEN BREACH AND KINK. 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, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON WAS DEFLATED. THE OK BUTTON ON THE CONSOLE WAS PRESSED WITHOUT RESOLVE. THE COAXIAL UMBILICAL CABLE WAS REPLACED BUT THE SYSTEM NOTICE PERSISTED. THE BALLOON CATHETER, SECOND COAXIAL CABLE AND ELECTRICAL UMBILICAL CABLE WERE REPLACED WITH RESOLVE. IT WAS ALSO REPORTED THAT THE BALLOON WAS NOT ABLE TO BE DEFLATED FULLY AS NOTED VIA FLUOROSCOPY, AND THE BALLOON CATHETER THEN DEFLATED FULLY WITH THE USE OF A MANUAL RETRACTION KIT. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION, AND IT WAS SUSPECTED THAT THERE WAS DAMAGE TO THE "BALLOON COATING." INFLATION WAS THEN PERFORMED, AND THE PROCEDURE CONTINUED. THE CASE WAS COMPLETED WITH RADIOFREQUENCY ABLATION. AFTER THE CASE, UPON ACCESSING THE HOME PANEL FOR THE CONSOLE TO SHUT DOWN, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED A REFRIGERANT LEAK DURING BALLOON INFLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2018: THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477554 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 90108

    Patients

    Seq Age Sex Outcome Treatment
    1