BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSTICK NEEDLE

    MDR report key: 14122398 · Received April 15, 2022

    Report

    Report Number
    2134265-2022-03757
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    January 9, 2022
    Report Date
    April 15, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER: AN INTRODUCER SHEATH, METAL CANNULA AND SHEATH DILATOR WERE RETURNED FOR ANALYSIS. IT WAS OBSERVED THAT THE SHEATH DILATOR, DISTAL TIP, WAS TORN.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23MAR2022. IT WAS REPORTED THAT THE WIRE WAS JAMMED ON THE SHEATH. AN ACCUSTICK NEEDLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE JAMMED ON THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DISTAL TIP OF THE SHEATH DILATOR WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415132 ACCUSTICK NEEDLE INTRODUCER, CATHETER GCB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown