BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY COOL PATH ABLATION CATHETER

    MDR report key: 1218588 · Received October 31, 2008

    Report

    Report Number
    2030404-2008-00017
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT CONSEQUENCES WERE REPORTED. ONE USED CATHETER WAS RECEIVED IN 2008. THE RETURNED CATHETER WAS VISUALLY AND FUNCTIONALLY EXAMINED. THERE WAS A FLAT LINE ELECTROGRAM SIGNAL FOR THE DISTAL TIP AND ELECTRODE BAND #2 PAIR. VISUAL INSPECTION ALSO NOTED A SLIGHT BEND ON THE CATHETER SHAFT 8.5 CM FROM THE DISTAL TIP. THE CATHETER WAS SYSTEMATICALLY DISSECTED TO DETERMINE THE ROOT CAUSE. NO ISSUES WERE FOUND AT THE CATHETER CONNECTOR. FURTHER DISSECTION NOTED INSULATION DAMAGE ON THE CONDUCTING WIRE CONNECTED TO ELECTRODE BAND #2. THE CONDUCTOR WIRES CONNECTED TO THE ELECTRODE BANDS ARE COATED WITH QUAD LAYER INSULATION TO PREVENT CONTACT WITH THE OTHER INTERNAL COMPONENTS AND WITH EACH OTHER. ADDITIONAL INSULATION COVERS THE CONDUCTOR WIRES TO FURTHER ISOLATE THE WIRES FROM OTHER INTERNAL COMPONENTS. IN THIS CASE, THE INSULATION BECAME DAMAGED AS A RESULT OF THE CONDUCTOR WIRE #2 BEING PINCHED AGAINST THE INTERNAL FLAT WIRE DURING REPEATED DEFLECTION OF THE CATHETER. ONCE THE INSULATION GETS DAMAGED, THERE IS A POTENTIAL FOR CONTACT AND A SHORT CIRCUIT BETWEEN THE CONDUCTOR WIRE AND THE INTERNAL FLAT WIRE. SINCE THE INTERNAL FLAT WIRE IS IN CONTACT WITH THE TIP ELECTRODE (#1), THERE IS THE POTENTIAL FOR A SHORT CONDITION BETWEEN ELECTRODES #2 AND THE TIP. THE DEVICE HISTORY RECORD FOR LOT NUMBER K02643 WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WERE PERFORMED AND REPORTED AS COMPLETE AND ACCEPTABLE. NO EVIDENCE OF A MANUFACTURING ERROR COULD BE FOUND. ALTHOUGH THIS TYPE OF EVENT IS UNDESIRABLE, IT IS OUR VIEW THAT THE RISK OF SERIOUS INJURY TO THE PT IS EXTREMELY LOW. MULTIPLE FACTORS MUST EXIST FOR AN INJURY TO OCCUR AS A RESULT OF A SHORT BETWEEN THE BAND AND TIP ELECTRODE. THESE DEVICES ARE USED BY PROCESSIONALS SPECIALIZING IN ELECTROPHYSIOLOGY AND CLOSE MONITORING OF THE ELECTROCARDIOGRAM IS ESSENTIAL TO EP PROCEDURES BOTH TO MAP THE ARRHYTHMIA AND TO DETERMINE EFFICACY OF AN ABLATION. THEREFORE, PHYSICIANS ROUTINELY REVIEW THE ELECTROCARDIOGRAM THROUGHOUT THE PROCEDURE. A SHORT WOULD BE IMMEDIATELY OBVIOUS AS AN UNACCEPTABLE ELECTROCARDIOGRAM. AS IN THIS CASE, NO SIGNAL WAS DETECTED BY THE PHYSICIAN. THE PHYSICIAN DID NOT CONTINUE THE ABLATION AND THE CATHETER WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO SIGNAL SENSED AT THE DISTAL TIP AND ELECTRODE BAND #2. THE CATHETER ALSO APPEARED TO BE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL PATH ABLATION CATHETER ABLATION CATHETER LPB IRVINE BIOMEDICAL, INC. 83388 K02643

    Patients

    Seq Age Sex Outcome Treatment
    1