BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIALSOURCE TRANSRADIAL ACCESS KIT

    MDR report key: 4113652 · Received September 17, 2014

    Report

    Report Number
    2183787-2014-00108
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 8, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K110051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    DURING A HEART CATH PROCEDURE, PART OF A RADIALSOURCE ACCESS KIT WIRE BROKE OFF INSIDE THE PATIENT. THE PATIENT REQUIRED SURGERY TO REMOVE THE PIECE OF WIRE. THE BREAK OF THE WIRE OCCURRED AT THE WELD. THE ACCESS SITE VESSEL CHARACTERISTICS APPEARED TO BE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575739 RADIALSOURCE TRANSRADIAL ACCESS KIT TRANSRADIAL INTRODUCER DYB GREATBATCH MEDICAL 10914-007 W18499988

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention