BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB

    MDR report key: 2564287 · Received March 21, 2012

    Report

    Report Number
    2030404-2012-00088
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSP OF THE RETURNED CATHETER REVEALED, THE CATHETER WAS RECEIVED IN TWO PIECES. THE CATHETER HAD BEEN CUT APPROX 5 CM FROM THE HANDLE DISTAL END. A KINK WAS NOTED APPROX 5.5 CM FROM THE DISTAL TIP OF THE CATHETER. FUNCTIONALITY TESTING OF THE CATHETER COULD NOT BE PERFORMED AS THE CATHETER WAS RECEIVED IN TWO PIECES. THE CATHETER WAS DISSECTED AT THE KINKED AREA REVEALING A SEVERE BEND IN THE FLAT WIRE AND ACTIVATION WIRE. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION FOR THE REPORTED REMOVAL DIFFICULTIES IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CARDIAC ABLATION PROCEDURE, THERE WERE DIFFICULTIES REMOVING A COOL PATH CATHETER. THE PHYSICIAN BEGAN THE PROCEDURE BY PERFORMING A REDO PVI/ATYPICAL ATRIAL FLUTTER ABLATION PROCEDURE USING A SWARTZ (B)(4) 8F INTRODUCER AND COOL PATH CATHETER. THE PHYSICIAN THEN ATTEMPTED TO PERFORM A VENTRICULAR TACHYCARDIA (VT) ABLATION AND CREATED GEOMETRY USING AN AGILIS LARGE CURL INTRODUCER AND A SECOND COOL PATH CATHETER. FOLLOWING GEOMETRY CREATION, THE AGILIS INTRODUCER WAS REMOVED AND THE CASE CONTINUED WITH THE COOL PATH CATHETER INSERTED VIA A RETROGRADE APPROACH THROUGH A NON-SJM 7F INTRODUCER. WHILE ATTEMPTING TO ADVANCE THE COOL PATH CATHETER THROUGH THE AORTIC VALVE TO GAIN ACCESS TO THE LEFT VENTRICLE, THE STEERING MECHANISM OF THE CATHETER BROKE CAUSING IT TO REMAIN IN A LOOPED POSITION. ATTEMPTS TO STRAIGHTEN THE CATHETER WITH THE USE OF ANOTHER CATHETER WERE UNSUCCESSFUL. THE PHYSICIAN CUT THE COOL PATH CATHETER SHAFT IMMEDIATELY DISTAL TO THE CATHETER HANDLE, INSERTED A 12F SHEATH OVER THE CATHETER AND WAS ABLE TO REMOVE THE CATHETER FROM THE PT VIA THE FEMORAL ARTERY WITH NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 83503 3290653

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR INQUIRY DECAPOLAR CATHETER:| SWARTS SL1 8F INTRODUCER: LOT AND MODEL NUMBER UNK| 2 SUPREME CATHETERS: LOT AND MODEL NUMBER UNK| LOT AND MODEL NUMBER UNK| CARDIO INTRODUCERS: MODEL AND LOT NUMBER UNK| NON SJM 7F INTRODUCER: LOT AND MODEL UNK| LOT AND MODEL NUMBER UNK| AGILIS LARGE CURL INTRODUCER:| COOL PATH CATHETER: MODEL 83503, LOT NUMBER UNK| 12F SHEATH: LOT AND MODEL NUMBER UNK