BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY ABLATION CATHETER

    MDR report key: 1689577 · Received May 12, 2010

    Report

    Report Number
    2030404-2010-00011
    Event Type
    Injury
    Date Received
    May 12, 2010
    Report Date
    April 13, 2010
    Manufacturer
    IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS DISCARDED AFTER THE PROCEDURE. THE LOT NUMBER WAS NOT AVAILABLE TO REVIEW THE DEVICE HISTORY RECORD. OTHER DEVICES WERE USED IN THE CASE. THE CAUSE FOR THE REPORTED HEMORRHAGE IS UNKNOWN. THE DESIGN HAS BEEN VALIDATED TO MEET THE BUCKLING LOAD REQUIREMENT (SIMULATION OF FORCE REQUIRED TO PERFORATE TISSUE). CATHETERS ARE 100% INSPECTED IN-PROCESS AND AT FINAL INSPECTION FOR ELECTRICAL AND MECHANICAL INTEGRITY TO ENSURE THEY MET THE SPECIFICATION REQUIREMENTS. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), VASCULAR PERFORATION IS AN INHERENT RISK AND THE CATHETER SHOULDN'T BE FORCED INTO THE VESSEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN REALIZED SOMETHING STRANGE AROUND THE CARDIAC SILHOUETTE. ON THE ECO IMAGE THEY CHECKED THE HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY ABLATION CATHETER CARDIAC PERCUTANEOUS ABLATION CATHETER LPB IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY 83503 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SJM 1500T11 RF GENERATOR| SHEATH| OPTIMA CATHETER