BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PATH 7F, 1304-CP-7-25-M-AB (USA)

    MDR report key: 1924733 · Received December 9, 2010

    Report

    Report Number
    2030404-2010-00259
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED NO ANOMALIES. THE CATHETER SUCCESSFULLY PASSED CONTINUITY, RESISTANCE AND EKG TESTING. STEERING FORCE TO CREATE A CURVE WAS WITHIN SPECIFICATION. THE CATHETER ALSO SUCCESSFULLY PASSED ABLATION SIMULATION TESTING, PRESSURE DROP TESTING, AND THE RATE TEST. THE TIP OF THE CATHETER WAS INSPECTED UNDER THE MICROSCOPE, NO ISSUE WAS OBSERVED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED PERICARDIAL EFFUSION REMAINS UNK. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 12/09/2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MANUFACTURER: (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER ABLATION WITH A COOL PATH CATHETER IN THE RIGHT VENTRICULAR OUTFLOW TRACT ON THE ANTEROSEPTAL WALL, A PERICARDIAL EFFUSION WAS NOTED. SIX HUNDRED CC OF FLUID WAS DRAWN OUT OF THE PERICARDIUM BY THE PHYSICIAN. A JP DRAIN WAS PLACED POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-M-AB (USA) NONE OAD ST. JUDE MEDICAL, IRVINE 84308 3208120

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention