BEUDAMED
    FDA Adverse Event Injury Summary report: N

    466P306X

    MDR report key: 6677254 · Received June 29, 2017

    Report

    Report Number
    1016427-2017-00417
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    January 1, 2010
    Report Date
    June 29, 2017
    Manufacturer
    CORDIS CASHEL
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: NAZZAL, M. (2010). COMPLICATIONS RELATED TO INFERIOR VENA CAVA FILTERS: A SINGLE-CENTER EXPERIENCE. ANN VASC SURG,24(4), 480-486. RETRIEVED NOVEMBER 11, 2009. THIS MEDWATCH IS BEING SUBMITTED FOR MULTIPLE PATIENTS WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY NAZZAL ET AL COMPLICATIONS RELATED TO INFERIOR VENA CAVA FILTERS: A SINGLE-CENTER EXPERIENCE, ANN VASC SURG (2010), 24(4): 480-486; THERE WERE 2 EVENTS OF HEMATOMA FORMATION AT SITE OF INSERTION FOR THE TRAPEASE ARM OF THE STUDY. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICES WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. ACCESS SITE HEMATOMAS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING THE PROCEDURE.  AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE UNSPECIFIED ALLEGATION AGAINST THE DEVICE IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY NAZZAL ET AL COMPLICATIONS RELATED TO INFERIOR VENA CAVA FILTERS: A SINGLE-CENTER EXPERIENCE, ANN VASC SURG (2010), 24(4): 480-486; THERE WERE 2 EVENTS OF HEMATOMA FORMATION AT SITE OF INSERTION FOR THE TRAPEASE ARM OF THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458112 466P306X CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS CASHEL 466P306X UNK

    Patients

    Seq Age Sex Outcome Treatment
    1