BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISLEEVE 14F

    MDR report key: 7535446 · Received May 22, 2018

    Report

    Report Number
    2134265-2018-04358
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 25, 2018
    Report Date
    April 25, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DYB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE ISLEEVE WAS RECEIVED BLOODY WITH THE DILATOR INSIDE OF THE SHEATH. THE SHEATH AND TIP WERE MICROSCOPICALLY EXAMINED. THE TIP IS DAMAGED. THERE IS PARTIAL EXPANSION ON 2 OF THE 3 SEAMS AS EXPECTED WITH DEVICE USAGE. THE SHEATH MATERIAL WAS SPLIT/TORN ON THE SEAM STARTING 21CM FROM THE TIP AND EXTENDING TO THE TIP. THE EDGES OF THE SPLIT/TEAR WERE SLIGHTLY JAGGED. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENT DUE TO THE DAMAGE. THE INVESTIGATION CONCLUSION IS OPERATIONAL CONTEXT AS THE PRODUCT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SEAM TEAR OCCURRED. A 14 F ISLEEVE INTRODUCER SHEATH WAS INSERTED. AN ACURATE BIOPROSTHESIS WAS IMPLANTED. DURING WITHDRAWAL OF THE ISLEEVE, THE PHYSICIAN NOTED THE EASE OF REMOVAL WAS POOR. A LONGITUDINAL SEAM TEAR WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374188 ISLEEVE 14F INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC - MAPLE GROVE H74939349140 21808207

    Patients

    Seq Age Sex Outcome Treatment
    1