BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVX® THROMBECTOMY SET

    MDR report key: 5159724 · Received October 19, 2015

    Report

    Report Number
    2134265-2015-07125
    Event Type
    Injury
    Date Received
    October 19, 2015
    Date of Event
    September 18, 2015
    Report Date
    September 21, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K133629
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF AN AVX THROMBECTOMY SET. WITH VISUAL AND TACTILE EXAMINATION SHOWED THAT THE PUMP SIDE WAS CUT OFF AND NOT RETURNED. THE TIP OF THE CATHETER WINDOWS STRETCHED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE AVX THROMBECTOMY CATHETER WAS SELECTED FOR USE AND BROKE INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE AVX THROMBECTOMY CATHETER WAS SELECTED FOR USE AND BROKE INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690554 AVX® THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 105039-001 0000190361

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention