BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR PROBES

    MDR report key: 7083099 · Received December 5, 2017

    Report

    Report Number
    1416980-2017-09563
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    September 26, 2017
    Report Date
    January 11, 2018
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DWP
    PMA / PMN Number
    K130896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND LOOSE PARTICULATE MATTER (PM) WAS IDENTIFIED ON THE OUTSIDE WALL OF THE INNER POUCH. THE PM WAS INSPECTED UNDER THE MICROSCOPE AND IT WAS DETERMINED TO BE FIBER. THE SIZE OF THE FIBER WAS DETERMINED TO BE ABOVE 0.80 MM SQUARED AND WAS OUT OF SPECIFICATION. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION WAS A MANUFACTURING ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE MATTER WAS DISCOVERED IN THE INNER POUCH OF A VASCULAR PROBE. THIS EVENT OCCURRED BEFORE USE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861145 VASCULAR PROBES DILATOR, VESSEL, SURGICAL DWP SYNOVIS SURGICAL INNOVATIONS NA SP17H251246250

    Patients

    Seq Age Sex Outcome Treatment
    1