BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISLEEVE 14F

    MDR report key: 7802401 · Received August 21, 2018

    Report

    Report Number
    2134265-2018-07326
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    May 11, 2018
    Report Date
    July 25, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DYB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN ISLEEVE DEVICE THAT WAS BLOODY. THE HUB, SHEATH AND TIP WERE MICROSCOPICALLY, TACTILE AND VISUALLY INSPECTED. INSPECTION REVEALED THE TIP WAS TORN IN TWO AREAS WITH INDENTATIONS/ABRASIONS, AND TWO SEAMS WERE SPLIT WITH ONE SEAM SPLIT 10 C, AND THE OTHER SPLIT SEAL FOR 13.5 CM. THERE WAS NO CRAZING IN THE DEVICE. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO THE REPORTED INSERTION DIFFICULTY, WHICH COULD NOT BE CONFIRMED BECAUSE THE CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED. WHILE THE REPORTED DIFFICULTY ADVANCING COULD NOT BE CONFIRMED AS CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED, THE DEVICE DAMAGE IS CONSISTENT WITH THE REPORTED EVENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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)(6). (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED 25 JULY 2018. DURING INTRODUCTION OF THE ACURATE TF¿ TRANSFEMORAL DELIVERY SYSTEM LOADED WITH THE ACURATE NEO¿ AORTIC BIOPROSTHESIS VALVE ((B)(4)), THE ACURATE TF¿ TRANSFEMORAL DELIVERY SYSTEM STUCK INSIDE THE ISLEEVE 14F INTRODUCER SHEATH RIGHT AFTER THE CROSSING OF HEMOSTATIC VALVE. IT WAS NOT POSSIBLE TO ADVANCE THE SYSTEM THROUGH THE SHEATH. A NEW INTRODUCER SHEATH, NEW VALVE AND NEW DELIVERY SYSTEM WERE USED TO FINISH PROCEDURE. THE CASE ENDED WITH A GOOD RESULT. THERE WAS NO HARM TO THE PATIENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE INTRODUCER SHEATH WAS TORN. 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
    643024 ISLEEVE 14F INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC - MAPLE GROVE H74939349140 21896973

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR