BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3944524 · Received July 18, 2014

    Report

    Report Number
    3002648230-2014-00119
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN ANALYZED. RESULTS OF EVALUATION OF RETURNED DEVICE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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 8 INJECTIONS WERE PERFORMED WITH THE CATHETER.

    Additional Manufacturer Narrative · 1

    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 8 INJECTIONS WERE PERFORMED WITH THE CATHETER. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. NO PRODUCT MALFUNCTION WAS REPORTED AND EVALUATION OF RETURNED DEVICE SHOWED NO INDICATION OF PRODUCT MALFUNCTION. VISUAL INSPECTION SHOWED THE CATHETER WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION SHOWED THAT THE CATHETER HAS BEEN USED FOR 8 INJECTIONS. THE CATHETER PASSED THE RETURNED PRODUCT INSPECTION AS PER SPECIFICATION.

    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 THERE WAS A PERFORATION OF THE PATIENT'S LEFT ATRIAL APPENDAGE DURING A CRYOABLATION PROCEDURE. CROSS SEPTUM ACCESS WAS THROUGH A ATRIAL SEPTAL DEFECT (ASD). ABLATIONS WERE PERFORMED IN THE LSPV, LIPV, AND RIPV. DURING POSITIONING IN RIPV, A DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED. PERICARDIOCENTESIS DONE, CPR STARTED AND CODE CALLED. ASPIRATED APPROXIMATE 2000CC BLOOD; 9 UNITS OF BLOOD GIVEN AND PRESSOR DRUGS GIVEN. PATIENT THEN TRANSFERRED TO OPERATING ROOM TO CLOSE PATIENT'S ASD. PATIENT HOSPITALIZED AND STABLE POST INTERVENTION. FOLLOW UP INFORMATION RECEIVED (B)(6) 2014 INDICATED THAT THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. DEVICE 1 OF 3, REFERENCE MFR REPORT: 3002648230-2014-00120 AND 3007798852-2014-00011

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421186 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 41720

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R FLEXCATH ADVANCE (B)(4), ACHIEVE (B)(4)