BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH DUO 7F CATHETER, 1304-CP2-7-25-MC-BD

    MDR report key: 2802594 · Received October 19, 2012

    Report

    Report Number
    2030404-2012-00271
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 22, 2012
    Report Date
    September 22, 2012
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO SJM. INVESTIGATION HAS NOT BEEN COMPLETED. WHEN ANALYSIS RESULTS ARE AVAILABLE A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LEFT SIDED ACCESSORY PATHWAY ABLATION, A COOL PATH DUO ABLATION CATHETER BECAME KINKED AND WAS DIFFICULT TO REMOVE FROM THE PT WHICH RESULTED IN THE HANDLE OF THE CATHETER BEING CUT IN ORDER TO RETRIEVE THE DEVICE. THE PHYSICIAN PLACED AN INQUIRY STEERABLE EP CATHETER WITH DIFFICULTY AND REPLACED IT TO ATTAIN SUCCESSFUL POSITION INTO THE CS. HE THEN PLACED A COOL PATH DUO ABLATION CATHETER THROUGH A FAST-CATH 12 CM INTRODUCER INTO THE LEFT VENTRICLE VIA RETROGRADE AORTIC APPROACH. IT BECAME KINKED AND REMOVAL WAS ATTEMPTED. IT WAS PULLED BACK INTO THE AORTA BUT THE PHYSICIAN WAS UNABLE TO PUT INTO NEUTRAL POSITION TO GET BACK INTO THE SHORT SHEATH. THE HANDLE TO THE ABLATION CATHETER WAS CUT AND A LONG SWARTZ BRAIDED SL 1 INTRODUCER WAS INSERTED INTO THE ARTERY. THE COOL PATH DUO CATHETER WAS PULLED OUT THROUGH THE LONG SHEATH AND REPLACED WITH A COOL FLEX ABLATION CATHETER WHICH WAS UNSUCCESSFUL IN REACHING THE NEEDED AREA FOR ABLATION SO IT WAS REPLACED WITH A MEDTRONIC MARINR ABLATION CATHETER WHICH WAS ALSO UNSUCCESSFUL. THE PT WILL BE RESCHEDULED FOR THE PROCEDURE NEEDING A TRANSSEPTAL PUNCTURE TECHNIQUE. THE PT WAS DISCHARGED HOME AND THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F CATHETER, 1304-CP2-7-25-MC-BD CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 88051 3300548

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR MEDTRONIC MARINR ABLATION CATHETER| COOL FLEX ABLATION CATHETER (MODEL AND LOT| FAST-CATH INTRODUCER (MODEL 406104, LOT UNKNOWN)| UNKNOWN)| FAST-CATH INTRODUCER (MODEL 406119, LOT 3745522)| SWARTZ BRAIDED SL 1 INTRODUCER (MODEL 407453,| LOT 6466614)| LOT 3739560)| INQUIRY STEERABLE EP CATHETER (MODEL 81945,