BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TRAPEASE

    MDR report key: 12144349 · Received July 9, 2021

    Report

    Report Number
    9616099-2021-04697
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    July 21, 2020
    Report Date
    July 9, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE REPORT ALSO REPRESENTS NOTIFICATION OF 9 EVENTS FOR FILTER - RETRIEVAL DIFFICULTY. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICES ARE UNKNOWN TRAPEASE FILTER BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS (EXCIMER LASER SHEATH-ASSISTED RETRIEVAL OF "CLOSED-CELL" DESIGN INFERIOR VENA CAVA FILTERS. JOURNAL OF THE AMERICAN HEART ASSOCIATION, 9(17), E017240. HTTPS://DOI.ORG/10.1161/JAHA.120.017240). A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT. AS REPORTED IN THE LITERATURE ARTICLE BY DESAI, K. R., XIAO, N., SALEM, R., KARP, J. K., RYU, R. K., & LEWANDOWSKI, R. J. (2020). EXCIMER LASER SHEATH-ASSISTED RETRIEVAL OF "CLOSED-CELL" DESIGN INFERIOR VENA CAVA FILTERS. JOURNAL OF THE AMERICAN HEART ASSOCIATION, 9(17), E017240. HTTPS://DOI.ORG/10.1161/JAHA.120.017240, 9. TRAPEASE FILTERS OUT OF 441 TOTAL PATIENTS IN STUDY REQUIRED LASER SHEATH ASSISTANCE RETRIEVALS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. THE REPORTED ¿FILTER-RETRIEVAL DIFFICULTY¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. PROCEDURAL FACTORS, SUCH AS OPERATOR TECHNIQUE, OR VESSEL CHARACTERISTICS, ALTHOUGH UNKNOWN, MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿WARNING: THE TRAPEASE FILTER SHOULD ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN DIAGNOSTIC AND PERCUTANEOUS INTERVENTIONAL TECHNIQUES, FOR INSTANCE PLACEMENT OF VENA CAVA FILTERS. ACCORDINGLY, CORDIS WILL NOT BE RESPONSIBLE FOR ANY DIRECT OR CONSEQUENTIAL DAMAGES OR EXPENSES RESULTING FROM USE BY UNTRAINED PERSONNEL. IF STRONG RESISTANCE IS MET DURING ANY STAGE OF THE PROCEDURE, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE BEFORE PROCEEDING.¿ ADDITIONALLY, THE IFU INSTRUCTS USERS TO INSPECT DEVICES PRIOR TO USE FOR ANY DAMAGES. WITHOUT A LOT NUMBER TO CONDUCT A PHR REVIEW, OR ANY OTHER PRODUCT INFORMATION, IT IS NOT POSSIBLE TO MAKE A CLINICAL DECISION WHETHER THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY DESAI, K. R., XIAO, N., SALEM, R., KARP, J. K., RYU, R. K., & LEWANDOWSKI, R. J. (2020). EXCIMER LASER SHEATH-ASSISTED RETRIEVAL OF "CLOSED-CELL" DESIGN INFERIOR VENA CAVA FILTERS. JOURNAL OF THE AMERICAN HEART ASSOCIATION, 9(17), E017240. HTTPS://DOI.ORG/10.1161/JAHA.120.017240, 9 TRAPEASE FILTERS OUT OF 441 TOTAL PATIENTS IN STUDY REQUIRED LASER SHEATH ASSISTANCE RETRIEVALS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039076 UNKNOWN TRAPEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CORPORATION 466P306X UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening