BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE

    MDR report key: 8142961 · Received December 7, 2018

    Report

    Report Number
    1820334-2018-03521
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 21, 2018
    Report Date
    March 6, 2019
    Manufacturer
    COOK INC
    Product Code
    OCY
    UDI-DI
    00827002535671
    PMA / PMN Number
    K082536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION EVALUATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION. NO PHOTOGRAPH WAS PROVIDED FOR REVIEW. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT # 9221140 FOUND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED NO OTHER COMPLAINTS HAVE BEEN ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 9221140. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: PRECAUTIONS: MANIPULATION OF WIRE GUIDE REQUIRES APPROPRIATE IMAGING CONTROL. USE CAUTION NOT TO FORCE OR OVER MANIPULATE THE WIRE GUIDE WHEN GAINING ACCESS. WHEN USING WIRE GUIDE THROUGH A METAL CANNULA/NEEDLE, USE CAUTION AS DAMAGE MAY OCCUR TO OUTER COATING. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. SEPARATION OF WIRE GUIDES IS COMMONLY OBSERVED WHEN A WIRE GUIDE IS WITHDRAWN THROUGH A METAL NEEDLE/CANNULA, AND IS CAUTIONED AGAINST IN THE (IFU). HOWEVER, THERE WAS NO MENTION OF A METAL INSTRUMENT BEING USED WITH THE DEVICE, SO THIS CANNOT BE CONFIRMED. BASED ON THE FINDINGS OF A PREVIOUS SIMILAR INVESTIGATION, IT IS POSSIBLE THAT USER TECHNIQUE OR PATIENT ANATOMY CONTRIBUTED TO THE DEVICE FAILURE. WITHOUT ADDITIONAL IMAGING OR PROCEDURAL INFORMATION HOWEVER, NEITHER OF THESE TWO POSSIBILITIES CAN BE CONFIRMED. A DEFINITIVE CONCLUSION COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    HHS/FDA SUS MW5081877 WAS RECEIVED AND RECONCILED WITH THIS PREVIOUSLY RECEIVED COMPLAINT AND INITIAL MEDWATCH REPORT FILED ON 07DEC2018.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 14JAN2019: AS REPORTED, THE CLINICIAN WAS ABLE TO REMOVE THE PIECES FROM THE PATIENT AND PROCEDURE WAS COMPLETED WITH THE USE OF A NEW WIRE. THE PATIENT OUTCOME POST-PROCEDURE WAS LISTED AS "FINE". THE WIRE WAS NOT WITHDRAWN THROUGH A NEEDLE AND DIFFICULTY REMOVING THE WIRE WAS EXPERIENCED BECAUSE THE WIRE WAS BROKEN. CONFIRMATION OF DEVICE RETURN HAS STILL NOT BEEN CONFIRMED.

    Description of Event or Problem · 0

    UPDATE (B)(6) 2019: COOK HAS BEEN ADVISED THAT THE DEVICE IS STILL IN THE POSSESSION OF THE HOSPITAL FOR INTERNAL RISK ASSESSMENT. IT IS UNLIKELY THAT THE PRODUCT WILL BE RETURNED.

    Description of Event or Problem · 0

    UPDATE 21DEC2018: HHS/FDA SUS REPORT MW5081877 WAS RECEIVED FROM THE FDA.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED, THE WIRE BROKE INSIDE THE PATIENT. THE FACILITY HAD SOME DIFFICULTY RETRIEVING THE FRAGMENTS. THE PHYSICIAN HAD TO MAKE AN ADDITIONAL CUT WITH THE LASER AND THE PHYSICIAN WAS ABLE TO GET THE FRAGMENTS OUT THE PATIENT. DEVICE IS AVAILABLE FOR EVALUATION. USER FACILITY MEDWATCH REPORT RECEIVED ON (B)(6) 2018. AS REPORTED, SURGEON INSERTED THE WIRE INTO THE LEFT URETER. THE WIRE BROKE IN THE URETER. BROKEN WIRE WAS REMOVED IN TWO PIECES. DEVICE IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE. ADDITIONAL INFORMATION: THE FACILITY WILL BE KEEPING THE DEVICE FOR THE OWN INTERNAL PROCESS. ONCE THE FACILITY INDICATES THE DEVICE IS AVAILABLE FOR RETURN, SHE WILL RETURN IT AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984193 AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY COOK INC 9221140 00827002535671

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR