BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 5243316 · Received November 23, 2015

    Report

    Report Number
    1820334-2015-00814
    Event Type
    Injury
    Date Received
    November 23, 2015
    Report Date
    July 28, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. CORRECTED DATA: (B)(4). DEVICE AVAILABLE FOR EVALUATION. INVESTIGATION EVALUATION: ONE USED JCD4.0-18-10.0-MPIS-SC-SST COMPONENT OF MPIS-401-10.0-SC-NT-SST SET WAS RETURNED FOR EVALUATION. INSPECTION OF THE DEVICE SHOWED THAT THE OUTER CATHETER SHAFT WAS FRACTURED APPROXIMATELY 2 CM FROM THE HUB, WITH APPROXIMATELY 3 MM OF STRETCHED MATERIAL PRESENT AT THAT LOCATION. THE OUTER SHAFT WAS ALSO KINKED APPROXIMATELY 3 CM FROM THE TIP, RESULTING IN THE TIP BEING BENT APPROXIMATELY 20 DEGREES. CUSTOMER TESTIMONY INDICATES THAT THE FRACTURED PORTION OF THE SHEATH WAS REMOVED FROM THE PATIENT VIA A SNARE. NO PORTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE COMPLAINT DEVICE WAS PRODUCED FROM EITHER LOT 6026944 OR 5951413. THE SHEATH COMPONENT OF THE COMPLAINT DEVICE IS MANUFACTURED BY COOK POLYMER TECHNOLOGY AS PART NUMBER PTWT-4.0-42-10. REVIEW OF THE DEVICE HISTORY RECORD FOR LOTS 6026944 AND 5951413 IDENTIFIED THE LOT NUMBERS FOR THE OUTER CATHETER TO BE LOT J256852H, J256852A, J256852M, J255812G, OR J255812F. IT IS FEASIBLE TO SUGGEST THE DEVICE ENCOUNTERED FORCES BEYOND ITS INTENDED DESIGN, WHICH CAUSED THE NOTED FAILURE.

    Description of Event or Problem · 1

    UPON REMOVING THE INTRODUCER SHEATH, THE SHEATH BROKE AND PIECE OF THE DEVICE WERE SNARED OUT OF THE PATIENT. .A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774666 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention