BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE

    MDR report key: 6669823 · Received June 27, 2017

    Report

    Report Number
    1820334-2017-01523
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    May 30, 2017
    Report Date
    September 20, 2017
    Manufacturer
    COOK INC
    Product Code
    OCY
    UDI-DI
    00827002535664
    PMA / PMN Number
    K082536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/EVALUATION: ONE USED AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE WAS RETURNED FOR INVESTIGATION. THE CORE IS SEPARATED FROM THE DISTAL TIP WELD. THE COIL IS ELONGATED AT THE DISTAL END. WELD IS PRESENT ON THE DISTAL END OF THE COIL. THE CORE WIRE IS 140.4 CM IN LENGTH. THE OVERALL LENGTH OF THE WIRE GUIDE (WITH ELONGATED COIL) IS 220.5 CM. THE DIAMETER OF THE WIRE GUIDE IS .03552 INCHES. THE CORE WIRE AND DIAMETER MEASUREMENTS ARE WITHIN SPECIFICATION. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS THREE NON-CONFORMANCES WHICH WERE IDENTIFIED AND SCRAPPED PRIOR TO FURTHER PROCESSING. A REVIEW OF COMPLAINT HISTORY REVEALED THIS IS THE ONLY REPORTED COMPLAINT ASSOCIATED TO COMPLAINT LOT NUMBER 7447851. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION; POTENTIAL ROOT CAUSE IS USER TECHNIQUE DUE TO REMOVAL OF THE WIRE GUIDE THROUGH THE NEEDLE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE MALFUNCTIONED DURING AN INTENDED PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE ON A PATIENT. THE MALFUNCTION WAS DESCRIBED AS THE WIRE SEPARATED FROM THE CORE WHEN REMOVED FROM THE DISPOSABLE TROCAR NEEDLE. IT WAS FURTHER REPORTED THAT THE REMAINING PART OF THE WIRE WAS STUCK INSIDE THE NEEDLE, WHICH WAS REMOVED WITH THE NEEDLE. THE DISPOSABLE TROCAR NEEDLE WAS DISPOSED OFF. 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
    450998 AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY COOK INC N/A 00827002535664

    Patients

    Seq Age Sex Outcome Treatment
    1