BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3961497 · Received July 28, 2014

    Report

    Report Number
    3002648230-2014-00127
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. BIN FILES AND FAILURE FILES WERE REVIEWED AND DID NOT SHOW ANY SYSTEM NOTICES FOR THE DATE OF EVENT. BIN FILES SHOWED THAT AT LEAST 11 INJECTIONS WERE PERFORMED WITH THE CATHETER.

    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 THE PATIENT HAD A PHRENIC NERVE PALSY DURING A CRYOABLATION PROCEDURE. TWO ABLATIONS WERE PERFORMED IN THE LSPV, LIPV AND RIPV WITHOUT ANY ISSUES. DURING THE FIRST ABLATION OF THE RSPV, THE DIAPHRAGM STOPPED RESPONDING AND THE ABLATION WAS TERMINATED AT 62 SECONDS (AT A TEMPERATURE OF -45 CELSIUS). ABLATION OF RSPV WAS COMPLETED USING A RADIOFREQUENCY (RF) CATHETER. THE DIAPHRAGM RESPONSE HAD NOT RECOVERED WHEN THE PATIENT LEFT THE ROOM AND THE PATIENT WAS PLACED IN MONITORING. THE PHRENIC NERVE PALSY STILL PERSISTED WHEN THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THOUGH THE PATIENT EXPERIENCES NO SYMPTOMS. ADDITIONAL INFORMATION RECEIVED (B)(4) 2015: THERE WAS NO TREATMENT, AND FLUOROSCOPY WAS PERFORMED FOR FOLLOW-UP. ALMOST REMISSION WAS CONFIRMED AT A FOLLOW-UP ON (B)(6) 2015.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PATIENT HAD A PHRENIC NERVE PALSY DURING A CRYOABLATION PROCEDURE. TWO ABLATIONS WERE PERFORMED IN THE LSPV, LIPV AND RIPV WITHOUT ANY ISSUES. DURING THE FIRST ABLATION OF THE RSPV, THE DIAPHRAGM STOPPED RESPONDING AND THE ABLATION WAS TERMINATED AT 62 SECONDS (AT A TEMPERATURE OF -45 CELSIUS). ABLATION OF RSPV WAS COMPLETED USING A RADIOFREQUENCY (RF) CATHETER. THE DIAPHRAGM RESPONSE HAD NOT RECOVERED WHEN THE PATIENT LEFT THE ROOM AND THE PATIENT WAS PLACED IN MONITORING. THE PHRENIC NERVE PALSY STILL PERSISTED WHEN THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THOUGH THE PATIENT EXPERIENCES NO SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437865 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 02326

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Other