BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHTHERAPY COOL PATH, 1304-CP-7-25-LC-BD

    MDR report key: 2577562 · Received May 14, 2012

    Report

    Report Number
    2030404-2012-00135
    Event Type
    Injury
    Date Received
    May 14, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 19, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LPB
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A THERAPY COOL PATH CATHETER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE SHAFT OF THE CATHETER WAS DETACHED APPROXIMATELY 3.2 CM FROM THE DISTAL END OF THE HANDLE. DUE TO THE CONDITION OF THE RETURN DEVICE, FUNCTIONAL TESTING WAS UNABLE TO BE COMPLETED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT 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 THERAPY COOL PATH CATHETER DURING AN ABLATION PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. TH CATHETER WAS INSERTED THROUGH AN SF ARTERIAL SHEATH VIA RETROGRADE APPROACH INTO THE LEFT VENTRICLE. THE CATHETER WAS DEFLECTED AND IMMEDIATELY IT WAS NOTED ON FLUOROSCOPY THE DEFLECTION WAS INCORRECT. AFTER SEVERAL ATTEMPTS WERE MADE TO STRAIGHTEN THE CURVE, THE PHYSICIAN WAS UNABLE TO RELEASE THE DEFLECTION. THE PHYSICIAN PULLED THE CATHETER BACK THROUGH TH AORTA IN AN ATTEMPT TO STRAIGHTEN THE CURVE; HOWEVER, THE CURVE WOULD NOT STRAIGHTEN. VASCULAR ACCESS WAS MADE VIA THE LEFT FEMORAL ARTERY AND A SNARE WAS INSERTED. THE PHYSICIAN SNARED THE TIP OF THE CATHETER AND ATTEMPTED TO STRAIGHTEN THE CURVE HOWEVER, WAS UNSUCCESSFUL. THE PHYSICIAN THEN CUT THE SHAFT OF THE CATHETER, PROXIMAL TO THE HANDLE, RELEASING THE STEERING MECHANISM. THE TIP OF THE CATHETER WAS STRAIGHTENED AND THE DEVICE WAS REMOVED FROM THE PATIENT. AT THAT POINT, THE PROCEDURE WAS CANCELLED. THE PATIENT'S CURRENT STATUS IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHTHERAPY COOL PATH, 1304-CP-7-25-LC-BD CARDIAC ABLATION PERCUTANEOUS CATHETER LPB ST. JUDE MEDICAL 88049 3390022

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention