BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUROUS CENTIMETER VESSEL SIZING CATHETER

    MDR report key: 6730561 · Received July 20, 2017

    Report

    Report Number
    1820334-2017-01821
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    June 16, 2017
    Report Date
    October 24, 2017
    Manufacturer
    COOK INC
    Product Code
    DQO
    UDI-DI
    00827002119161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INVESTIGATION - EVALUATION A REVIEW OF MANUFACTURING INSTRUCTIONS, TRENDS, COMPLAINT HISTORY, DEVICE HISTORY RECORD, SPECIFICATIONS, QUALITY CONTROL DATA, AND VISUAL INSPECTION / FUNCTIONAL TESTING OF FOUR UNOPENED DEVICES FROM THE SAME LOT AS THE DEVICE ALLEGED IN THIS REPORT WAS CONDUCTED DURING THE INVESTIGATION. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE USED DEVICE WAS NOT RETURNED. FOUR SEALED (UNUSED) AUROUS CENTIMETER VESSEL SIZING CATHETER (N5.0-35-100-P-10S-PIG-CSC-20) WERE RETURNED FROM LOT 6922581(SAME LOT AS USED DEVICE). TWENTY-ONE MARKER BANDS WERE PRESENT ON EACH OF THE DEVICES. A PORTION OF CATHETER DISCOLORATION IS NOTED ON DEVICE 1. PORTION OF CATHETER UNDER LABEL IS NOT DISCOLORED. ALL FOUR CATHETERS WERE TESTED FOR VISUALIZATION OF TIP USING FLUOROSCOPY. THREE SEPARATE TEST WERE PERFORMED ON ALL FOUR DEVICES. FIRST TEST WAS A DIRECT IMAGE OF THE DEVICE. THE SECOND TEST USED A PLEXIGLASS MODEL WITH EACH OF THE DEVICES, THIS MIMICS IN PATIENT USE. THE THIRD TEST USED ALUMINUM SLAB MODEL, WHICH ALSO MIMICS IN PATIENT USE. ALL FOUR DEVICES PASSED ALL THREE TESTS. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY, "THE PHYSICIAN STATED THAT THEY COULD NOT SEE THE TIP UNDER FLURO, PRODUCT IS NO GOOD." THERE WERE NO KNOWN ADVERSE PATIENT CONSEQUENCES REPORTED AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510449 AUROUS CENTIMETER VESSEL SIZING CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC 00827002119161

    Patients

    Seq Age Sex Outcome Treatment
    1