BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENTSON STRAIGHT HEPARIN COATED FIXED CORE WIRE GUIDE

    MDR report key: 4289893 · Received November 13, 2014

    Report

    Report Number
    1820334-2014-00585
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    July 31, 2014
    Report Date
    October 22, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DURING THE COURSE OF INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, MFG INSTRUCTIONS FOR USE (MI), QUALITY CONTROL (QC) AND SPECS WAS CONDUCTED IN ADDITION TO A VISUAL INSPECTION OF THE RETURNED COMPLAINT WIRE GUIDE, WHICH WAS RECEIVED IN A DAMAGED CONDITION. A VISUAL EXAMINATION CONFIRMED THAT THE DISTAL CONNECTION HAS SEPARATED, ALLOWING THE COIL TO UNRAVEL AND BECOME ELONGATED. PER QUALITY CONTROL SPEC, THIS WIRE GUIDE IS INSPECTED 100% FOR SECUREMENT OF BOTH DISTAL AND PROXIMAL CONNECTIONS, LENGTH AND DIAMETERS ARE INSPECTED WITH METER SCALES AND RING GAGES RESPECTIVELY. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE PRODUCT IS PRODUCED AS INTENDED. A REVIEW OF RECORDS REVEALED THAT IN THE PAST, THIS TYPE OF DEVICE FAILURE HAS GENERALLY BEEN ASSOCIATED WITH THE WIRE GUIDE BEING DAMAGED BY WITHDRAWAL AND/OR MANIPULATED THROUGH THE NEEDLE OR OTHER INSTRUMENT. AT THIS TIME WE ARE UNABLE TO DETERMINE WITH CERTAINLY THE ROOT CAUSE FOR THE REPORTED DIFFICULTY. THE APPROPRIATE INTERNAL PERSONAL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT (QERA), NO ADD'L MITIGATION ACTIVITIES WILL BE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A MALE PT HAD UNDERWENT A GJ TUBE CHANGE AND THE PHYSICIAN WAS USING A BENTSON CEREBRAL GUIDEWIRE TO CHANGE A PT'S GJ TUBE. THE GUIDEWIRE BROKE AND FRAYED. NO HARM CAME TO THE PT. THE EVENT OCCURRED WHEN THE NEW TUBE WAS ALREADY IN PLACE AND THE FACILITY WAS REMOVING THE WIRE TO FINISH THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    A MALE PATIENT HAD UNDERWENT A GJ TUBE CHANGE AND THE PHYSICIAN WAS USING A BENTSON CEREBRAL GUIDEWIRE TO CHANGE A PATIENT'S GJ TUBE. THE GUIDEWIRE BROKE AND FRAYED. NO HARM CAME TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734369 BENTSON STRAIGHT HEPARIN COATED FIXED CORE WIRE GUIDE WIRE, GUIDE, CATHETER DQX COOK, INC. NA 5005009

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR