BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLAR INSTRUMENTS

    MDR report key: 5084178 · Received June 4, 2004

    Report

    Report Number
    1625382-2004-00001
    Event Type
    Malfunction
    Date Received
    June 4, 2004
    Date of Event
    May 7, 2004
    Report Date
    May 21, 2004
    Manufacturer
    MILLAR INSTRUMENTS, INC.
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY ATTACHMENT: SUBJECT DEVICE WAS RETURNED FROM THE (B)(4) BY THE USER VIA THE PRODUCT DISTRIBUTOR (IMPORTER) IN THE (B)(4). THE USER AND IMPORTER RESIDE AND PRACTICE IN THE (B)(4) AND MAY NOT BE FAMILIAR WITH DETAILS OF U.S. FDA REPORTING PROCEDURES. THE USER/IMPORTER PROVIDED INCOMPLETE INFORMATION (INCLUDED AS PAGES 3 AND 4 OF THIS SUBMISSION), AND MANUFACTURER COMPLETED INFORMATION TO EXTENT POSSIBLE ON PAGES 1 AND 2. THE PRODUCT MALFUNCTION WAS DETECTED AS A LOSS OF SIGNAL FROM DISTAL SENSORS. UPON REMOVAL OF THE DEVICE FROM THE PATIENT, IT WAS FOUND TO BE MECHANICALLY BROKEN YET INTACT. USER WAS CONCERNED THAT FURTHER DISINTEGRATION COULD HAVE LED TO PATIENT INJURY. UPON RECEIPT MANUFACTURER PERFORMED VISUAL AND MECHANICAL INSPECTION OF CATHETER COMPONENTS. RESULTS OF INSPECTION INDICATED THAT AN INTERNAL COMPONENT PROVIDING STRUCTURAL RIGIDITY AT THE POINT WHERE THE CATHETER BROKE WAS SLIGHTLY SHORTER THAN THE SPECIFIED LENGTH, AND COULD HAVE BEEN RELATED TO THE MALFUNCTION. IT HAS NOT YET BEEN POSSIBLE TO DETERMINE WHAT OTHER FACTORS CONTRIBUTED TO THE MALFUNCTION (USER TECHNIQUE, ETC.). MANUFACTURER CONTINUES TO EVALUATE THE PRODUCT MALFUNCTION INCLUDING THE TESTING OF CATHETERS FROM THE SAME AND SIMILAR PRODUCTION LOTS. EVIDENCE SO FAR SUGGESTS THE OUT-OF-SPEC CONDITION IS RELATED TO WORKMANSHIP OF ONE ASSEMBLER. ONLY TWO SCD-484 MODEL CATHETERS WERE PRODUCED BY THIS ASSEMBLER AND SHIPPED TO END USERS: THE ONE THAT MALFUNCTIONED, AND ANOTHER THAT WAS RETURNED TO THE MANUFACTURER (AT MANUFACTURER'S REQUEST) FOR EVALUATION FOLLOWING THE REPORT OF THE EVENT. MANUFACTURER WILL DETERMINE IF ANY SIMILAR PRODUCT MODELS WERE AFFECTED AND WILL DETERMINE IF FURTHER REMEDIAL ACTION IS REQUIRED.

    Description of Event or Problem · 1

    SCD-484 INTRODUCED THROUGH THE AORTA USING 4F PERCUTANEOUS INTRODUCER. FOLLOWING RE-POSITIONING OF CATHETER SUDDEN LOSS OF PRESSURE SIGNAL. CATHETER WAS REMOVED AND IT HAD FRACTURED JUST BEYOND THE MICROMANOMETER. A SINGLE WIRE WAS HOLDING DISTAL PORTION OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLAR INSTRUMENTS PV CATHETER OBJ MILLAR INSTRUMENTS, INC. SCD-484 LO33323

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Life Threatening