BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1490557 · Received October 5, 2009

    Report

    Report Number
    2090040-2009-00006
    Event Type
    Malfunction
    Date Received
    October 5, 2009
    Date of Event
    September 3, 2009
    Report Date
    October 5, 2009
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NLI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ASCENT HEALTHCARE SOLUTIONS RESTERILIZES THIS MODEL OF ANGIOGRAPHIC CATHETER THROUGH OUR OPEN/UNUSED PROCESS. HOWEVER, THE DEVICE WAS NOT RETURNED TO ASCENT FOR EVALUATION AND THE PACKAGING WAS NOT SAVED. IT WAS DETERMINED THAT THIS (B) (6) WAS NEVER SENT THIS ITEM NUMBER FROM ASCENT HEALTHCARE SOLUTION. HOWEVER, TWO OTHER FACILITIES IN (B) (6) NETWORK WERE SENT THIS ITEM IN THE PAST. PICTURES OF THE DEVICE IN THIS INCIDENT WERE PROVIDED, BUT DO NOT CONFIRM THE DEVICE WAS RESTERILIZED BY ASCENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED, BECAUSE THE SALES ORDER INFORMATION WAS NOT PROVIDED. A REVIEW OF THE PROCEDURES RELATED TO OPEN/UNUSED DEVICE INSPECTION WAS PERFORMED AND THE PROCEDURES ARE APPROPRIATE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE CATHETER BROKE INTO PIECES INSIDE THE PATIENT. A SECOND PROCEDURE WAS PERFORMED THE FOLLOWING DAY TO REMOVE THE PIECES FROM THE PATIENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLI NLI ASCENT HEALTHCARE SOLUTIONS 10722104

    Patients

    Seq Age Sex Outcome Treatment
    1