BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY STEERABLE CATH. 7F, 1120-7-17-H

    MDR report key: 2191548 · Received July 20, 2011

    Report

    Report Number
    2030404-2011-00218
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ST JUDE MEDICAL, IRVINE
    Product Code
    DRF
    PMA / PMN Number
    K961924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED SIX TWISTS OR BENDS AT THE CURVE SECTION OF THE CATHETER. FUNCTIONAL TESTING OF THE CATHETER REVEALED THE DEFLECTION MECHANISM WAS FUNCTIONAL AND THE ACTIVATION WIRE REMAINED CONNECTED AS PER THE DESIGN REQUIREMENTS. WHEN THE CATHETER WAS DEFLECTED SLIGHT TIP MOVEMENT WAS NOTED BUT DUE TO THE DAMAGE TO THE CATHETER, IT DID NOT CREATE A CURVE THAT MATCHED THE TEMPLATE REQUIREMENTS. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING THE INQUIRY STEERABLE CATHETER FOR AN ABLATION PROCEDURE IT WOULD NOT STRAIGHTEN AND WAS DIFFICULT TO REMOVE FROM THE PT. DURING AN ATRIAL FLUTTER ABLATION PROCEDURE THE INQUIRY STEERABLE CATHETER WAS PLACED IN THE RIGHT ATRIUM WITH NO INITIAL ISSUES WITH CATHETER PLACEMENT OR PERFORMANCE. AFTER THE ATRIAL FLUTTER WAS SUCCESSFULLY ABLATED, THE CATHETER WAS REMOVED FROM THE PT. ANOTHER TACHYCARDIA WAS INDUCED AND THE PHYSICIAN PROCEEDED WITH A SLOW PATHWAY ABLATION. ONCE THAT ABLATION WAS COMPLETE, THE PHYSICIAN REINSERTED THE INQUIRY STEERABLE CATHETER THROUGH THE IVC TO CHECK FOR BI-DIRECTIONAL BLOCK. SOME TORQUE WAS USED BY THE PHYSICIAN TO POSITION THE CATHETER AND THE CATHETER KINKED. THE PUSH/PULL MECHANISM WAS NONFUNCTIONAL AND THE CATHETER APPEARED IN A KNOT ON FLUOROSCOPY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE CATHETER BACK INTO THE ATRIUM TO SEE IF THE CATHETER WOULD OPEN UP (UNKNOT) WITHOUT SUCCESS. THE PHYSICIAN THEN ATTEMPTED TO USE THE ABLATION CATHETER TO STRAIGHTEN OUT THE CATHETER WITH NO SUCCESS. AFTER 25 MINUTES, ALL OTHER CATHETERS AND SHEATHS WERE REMOVED FROM THE HEART/VESSELS AND THE CATHETER WAS ABLE TO STRAIGHTEN OUT AND BE REMOVED. VISUAL INSPECTION OF THE CATHETER AFTER IT WAS REMOVED REVEALED A KINK BUT NO KNOT. FOLLOWING THE PROCEDURE THE PT DEVELOPED BLEEDING FROM THE GROIN SITES THAT RESOLVED WITH DIRECT APPLICATION OF PRESSURE AND BEDREST. THE PT'S CURRENT STATUS IS LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY STEERABLE CATH. 7F, 1120-7-17-H CATHETER, ELECTRODE, RECORDING DRF ST JUDE MEDICAL, IRVINE 81120 3381079

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR