BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEZOR MAX CARDIAC CRYOABLATION CATHETER

    MDR report key: 2181747 · Received July 27, 2011

    Report

    Report Number
    3002648230-2011-00096
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IT WAS DISCARDED AFTER THE PROCEDURE SINCE NO MALFUNCTION OCCURRED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    QUESTIONABLE RSPV ELECTROGRAMS PERSISTED FOLLOWING A ROUTINE CRYOABLATION PROCEDURE WITH THE ARCTIC FRONT CATHETER AND FLEXCATH SHEA TH, AND THE PHYSICIAN ELECTED TO USE FREEZOR MAX CATHETER FOR FOCAL TOUCH-UP. THIS WAS A SINGLE TRANSSEPTAL PROCEDURE AND, AS SUCH, FOCAL LESIONS WERE PERFORMED WITHOUT A MAPPING CATHETER OR CIRCULAR CATHETER TO PROVIDE SIMULTANEOUS PV ELECTROGRAMS INFORMATION. AFTER TWO FOCAL LESIONS, AN RSPV ANGIOGRAM WAS PERFORMED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE POSITION OF THE FREEZOR MAX CATHETER RELATED TO THE RSPV. A 1-2 ADDITIONAL FOCAL LESIONS WERE APPLIED WITHOUT APPARENT CHANGE IN LOCAL EGM (PROXIMAL OR DISTAL ABLATION SIGNALS) AND PHYSICIAN DECIDED ALL THE INTENDED ABLATION WAS COMPLETE. THE FLEXCATH SHEATH AND FREEZOR MAX CATHETER WERE WITHDRAWN INTO THE RIGHT ATRIUM. AT THE TIME THESE WERE WITHDRAWN ACROSS THE SEPTUM THE FREEZOR MAX CATHETER WAS VISIBLE BEYOND THE SHEATH TIP ON FLUOROSCOPY. THE PHYSICIAN PROCEEDED TO BEGIN TO COMPLETE HIS BASIC EPS PACING AND RECORDING. WITHIN LESS THAN 5 MINUTES, THE PATIENT'S BLOOD PRESSURE DROPPED ABRUPTLY. FOLLOWING THE ABRUPT DROP IN BLOOD PRESSURE, THE HEART WAS OBSERVED ON FLUOROSCOPY AND APPEARED TO BE MOVING MINIMALLY. BLOOD PRESSURE WAS 70/40. STAT ECHO WAS ORDERED. PROTAMINE AND DOPAMINE WERE ORDERED. THE PATIENT WAS PROMPTLY PREPPED FOR PERICARDIOCENTESIS, WHICH YIELDED 720CC OF BLOOD. ECHO STAFF ARRIVED AFTER THE PERICARDIOCENTESIS AND CONFIRMED NO FURTHER PERICARDIAL EFFUSION. THE PATIENT LEFT THE EP LAB WITH NORMAL VITAL SIGNS AND A PERICARDIAL DRAIN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR MAX CARDIAC CRYOABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 239F3 02843

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention