BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 3151987 · Received June 7, 2013

    Report

    Report Number
    3002648230-2013-00085
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE 5TH ABLATION OF THE PROCEDURE (FIRST ABLATION AT RSPV), PATIENT¿S HEART RATE INCREASED SLIGHTLY AND BLOOD PRESSURE BEGAN TO TREND DOWN. THE ABLATION WAS IMMEDIATELY TERMINATED AT 100 SECONDS. THE PERICARDIUM WAS INSPECTED BY (B)(6) AND A MODERATE TO SEVERE PERICARDIAL EFFUSION WAS NOTED. HEPARIN WAS STOPPED. PROTAMINE WAS ADMINISTERED. CRYOABLATION CATHETER, SHEATH AND MAPPING CATHETER WERE ALL PULLED BACK INTO THE RIGHT ATRIUM AS THE SUBXIPHOID AREA WAS PROMPTLY PREPPED FOR PERICARDIOCENTESIS. A TOTAL OF 950 CC OF BLOOD WAS REMOVED FROM THE PERICARDIUM. PATIENT REMAINED STABLE DURING THIS EVENT AND REMAINDER OF PROCEDURE. PATIENT WAS MONITORED IN ELECTROPHYSIOLOGY LAB FOR 45 MINUTES FOLLOWING PERICARDIOCENTESIS. INR NORMALIZED AND ALL GROIN SHEATHS WERE REMOVED. THREE OF THE FOUR VEINS WERE CONSIDERED ISOLATED AT THE TIME OF THE EVENT; THE RIPV HAD NOT YET BEEN ATTEMPTED BEFORE THE ABLATION PROCEDURE WAS TERMINATED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013 AND WAS DOING WELL. IN REVIEW OF THE PROCEDURE, THE PHYSICIAN STATED THAT THE PATIENT¿S ANATOMY AND TRANSSEPTAL ACCESS LOCATION MADE THE APPROACH TO THE RSPV MORE DIFFICULT THAN USUAL. DEVICE 1 OF 3, REFERENCE MFR REPORTS: 3002648230-2013-00084, 3007798852-2013-00006

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253319 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 67325

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention ARCTIC FRONT ADVANCE (B)(4), ACHIEVE (B)(4)