BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3122357 · Received May 21, 2013

    Report

    Report Number
    3002648230-2013-00078
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT IS SIMILAR TO THE ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER MARKETED IN THE US. THE BIN FILES SHOW WERE REVIEWED AND SHOWED SYSTEM NOTICE MESSAGE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION) AT 163 SECONDS INTO THE SECOND INJECTION WITH CATHETER 2AF283 / (B )(4)AT THE THAWING PHASE. BIN FILES SHOW 2 INJECTIONS WERE PERFORMED WITH CATHETER 2AF283 / (B)(4), THEN CATHETER WAS EXCHANGED AND 3 INJECTIONS WERE PERFORMED WITH 2AF283 / (B)(4) ON (B)(6) 2013. ADDITIONAL INVESTIGATION WILL BE PERFORMED FOLLOWING RETURN OF DEVICES. THE ARCTIC FRONT ADVANCE TECHNICAL MANUAL INDICATES: "STEERABLE SHEATH COMPATIBILITY - USE ONLY THE 12 FR FLEXCATH SHEATH FAMILY WITH THE ARCTIC FRONT ADVANCE CRYOBALLOON. USING ANOTHER SHEATH MAY DAMAGE THE CATHETER OR BALLOON SEGMENT."

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT IS SIMILAR TO THE ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER MARKETED IN THE US. THE BIN FILES WERE REVIEWED AND SHOWED SYSTEM NOTICE MESSAGE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION) AT 163 SECONDS INTO THE SECOND INJECTION WITH CATHETER 2AF283 / 27826-99 AT THE THAWING PHASE. BIN FILES SHOW 2 INJECTIONS WERE PERFORMED WITH CATHETER 2AF283 / 27826-99, THEN CATHETER WAS EXCHANGED AND 3 INJECTIONS WERE PERFORMED WITH 2AF283 / 21642-66 ON 04/22/2013. THIS REPORT INCLUDES THE RESULTS OF DEVICE ANALYSIS FOR CATHETER 2AF283 / 21642-66. FOR THE DEVICE ANALYSIS RESULTS FOR CATHETER 2AF283 / 27826-99, REFER TO MFR REPORT: 3002648230-2013-00077. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION OF 2AF283 / 21642-66 SHOWED THAT THE CATHETER WAS INTACT WITH NO APPARENT ISSUES. VERIFICATION OF THE SMART CHIP FILE INDICATED THE CATHETER WAS USED FOR 3 INJECTIONS. THE CATHETER FAILED THE PERFORMANCE TEST DUE TO SYSTEM NOTICE #(B)(4) UPON CONNECTION TO THE CONSOLE. PRESSURE TEST AND DISSECTION REVEALED AN OUTER BALLOON PINHOLE. FURTHER DISSECTION AND PRESSURE TESTS SHOWED THE INNER BALLOON WAS INTACT. THE OUTER BALLOON PINHOLE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED PHRENIC NERVE PALSY. PHRENIC NERVE INJURY IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CARDIAC CRYOABLATION PROCEDURES. AS PER THE INFORMATION RECEIVED BY MEDTRONIC, THE ARCTIC FRONT ADVANCE CATHETERS WERE BEING USED WITH A SHEATH THAT IS CONTRARY TO THE APPROVED LABELING. THE ARCTIC FRONT ADVANCE TECHNICAL MANUAL INDICATES: "STEERABLE SHEATH COMPATIBILITY - USE ONLY THE 12 FR FLEXCATH SHEATH FAMILY WITH THE ARCTIC FRONT ADVANCE CRYOBALLOON. USING ANOTHER SHEATH MAY DAMAGE THE CATHETER OR BALLOON SEGMENT."

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT AN AIR EMBOLISM WAS NOTED DURING CRYOABLATION PROCEDURE. DURING THE SECOND ABLATION WITH ARCTIC FRONT ADVANCE CATHETER MODEL 2AF283, SERIAL NO. (B)(4), THE CRYOCONSOLE SHOWED SYSTEM NOTICE MESSAGE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION). THE CATHETER WAS REPLACED WITH ARCTIC FRONT ADVANCE CATHETER MODEL 2AF283, SERIAL NO. (B)(4) AND THE PROCEDURE CONTINUED. APPROXIMATELY 120S INTO THE FOURTH CRYOABLATION OF THE CASE (SECOND CRYOABLATION WITH THIS CATHETER), ST SEGMENT ELEVATION WAS NOTED. FLUOROSCOPY SHOWED A LARGE AIR BUBBLE IN THE LEFT VENTRICLE. INFORMATION RECEIVED BY MEDTRONIC INDICATES THAT THE PATIENT EXPERIENCED EFFECTS OF AIR EMBOLISM. DIAGNOSIS IS CURRENTLY UNKNOWN. AS OF (B)(6) 2013, THE PATIENT WAS SITTING UP IN BED AND TALKING. THE PHYSICIAN WAS USING A BARD DIREX STEERABLE SHEATH WITH THE ARCTIC FRONT ADVANCE CATHETER. ALSO IN THE LEFT ATRIUM WAS A STJ FIXED SHEATH AND BSW LASSO CATHETER THROUGH A SECOND TRANSSEPTAL PUNCTURE. THE BARD SHEATH WAS BEING FLUSHED BY COOLFLOW PUMP. NO ERRORS NOTED. DEVICE 2 OF 2, REFERENCE MFR REPORT: 3002648230-2013-00077.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE FOLLOWING EVENTS OCCURRED DURING A CRYOABLATION PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR THE PROCEDURE. DURING THE SECOND ABLATION WITH ARCTIC FRONT ADVANCE CATHETER MODEL 2AF283, SERIAL NO. (B)(4), ST SEGMENT ELEVATION WAS NOTED. THE CRYOCONSOLE SHOWED SYSTEM NOTICE MESSAGE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION). THE PATIENT BECAME HYPOTENSIVE. FLUOROSCOPY SHOWED A LARGE GAS BUBBLE IN THE LEFT VENTRICLE. THE PHYSICIAN HAD TO RESUSCITATE THE PATIENT. AFTER A FEW MINUTES, PATIENT WAS HEMODYNAMICALLY STABLE WITHOUT SUPPORT AND THE GAS DISAPPEARED. THE CATHETER WAS REPLACED WITH ARCTIC FRONT ADVANCE CATHETER MODEL 2AF283, SERIAL NO. (B)(4) AND THE PROCEDURE CONTINUED. WITH THE SECOND CATHETER, THE PHYSICIAN COMPLETED ABLATIONS IN THE LEFT SUPERIOR AND LEFT INFERIOR PULMONARY VEINS. WHILE ABLATING A RIGHT SIDED PULMONARY VEIN, THE PHYSICIAN REPORTED SEEING AN ERROR MESSAGE ON THE CRYOCONSOLE. AT ABOUT THE SAME TIME, THE PHYSICIAN SAW THAT THE PATIENT HAD A PHRENIC NERVE PALSY AND HE DECIDED TO END THE PROCEDURE. INFORMATION INITIALLY RECEIVED BY MEDTRONIC INDICATES THAT THE PATIENT EXPERIENCED EFFECTS OF AIR EMBOLISM. AS OF (B)(6) 2013, THE PATIENT WAS SITTING UP IN BED AND TALKING. AS OF (B)(6) 2013, THE PATIENT WAS REPORTED TO BE OK WITH NO SYMPTOMS. THE PHYSICIAN WAS USING A BARD DIREX STEERABLE SHEATH WITH THE ARCTIC FRONT ADVANCE CATHETER. ALSO IN THE LEFT ATRIUM WAS A STJ FIXED SHEATH AND BSW LASSO CATHETER THROUGH A SECOND TRANSSEPTAL PUNCTURE. THE BARD SHEATH WAS BEING FLUSHED BY COOLFLOW PUMP. DEVICE 2 OF 2, REFERENCE MFR REPORT: 3002648230-2013-00077.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223562 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization ARCTIC FRONT ADVANCE 2AF283, SERIAL NO. (B)(4)