BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE

    MDR report key: 7902990 · Received September 24, 2018

    Report

    Report Number
    1820334-2018-02824
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    September 6, 2018
    Report Date
    October 30, 2018
    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
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPH OR IMAGING WAS PROVIDED. WITHOUT THE COMPLAINT DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY OBSERVED FOUR NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. HOWEVER, ALL RELEVANT NONCONFORMING DEVICES WERE SCRAPPED, AND ALL REMAINING DEVICES IN THE LOT UNDERWENT QUALITY CONTROL ACTIVITIES SUCH AS TENSILE TESTS, SURFACE DAMAGE CHECKS, AND OUTER DIAMETER GAGING. SINCE THESE 100% INSPECTION PROCEDURES ARE IN PLACE AND NO OTHER COMPLAINTS HAVE ORIGINATED FROM THIS LOT, NO NONCONFORMING DEVICES ARE SUSPECTED IN HOUSE OR IN THE FIELD. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8935584. THIS DEVICE IS SHIPPED WITH THE INSTRUCTIONS FOR USE (IFU) WHICH CONTAINS THE FOLLOWING RELEVANT PRECAUTION: ¿ MANIPULATION OF THE WIRE GUIDE REQUIRES APPROPRIATE IMAGING CONTROL. USE CAUTION NOT TO FORCE OR OVER MANIPULATE THE WIRE GUIDE WHEN GAINING ACCESS. THE DEVICE MANUFACTURING RECORD SHOWED NO GAPS IN PRODUCTION OR PROCESSING CONTROLS. SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. THERE IS NOT ENOUGH INFORMATION REGARDING THE PROCEDURE, THE PATIENT, AND THE EQUIPMENT TO ISOLATE A MAIN CAUSE OF FAILURE. UNRAVELING OF WIRE GUIDES IS COMMONLY OBSERVED WHEN A WIRE GUIDE IS WITHDRAWN THROUGH A METAL NEEDLE/CANNULA, AS IS CAUTIONED AGAINST IN THE INSTRUCTIONS FOR USE (IFU), BUT THE CUSTOMER DID NOT REPORT USE OF ANY NEEDLE OR DEVICE WITH A METAL CANNULA. POTENTIALLY TORTUOUS ANATOMY MAY HAVE ATTRIBUTED TO THE EVENT, BUT NO INFORMATION WAS PROVIDED ABOUT PATIENT ANATOMY. CONSIDERING THE QUALITY CONTROL PROCEDURES IN PLACE, A MANUFACTURING CAUSE OF FAILURE IS NOT SUSPECTED. A DEFINITIVE CONCLUSION REGARDING THE MAIN CAUSE OF FAILURE COULD NOT BE MADE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. 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.

    Description of Event or Problem · 0

    THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Description of Event or Problem · 0

    REPORT MW5080040 RECEIVED FROM FDA ON 25OCT2018. WIRE BEGAN TO UNRAVEL AS IT WAS BEING WITHDRAWN INTRA-OPERATIVELY. THE GUIDE WIRE REMAINED INTACT NOT FRAYED AND DID NOT FRAGMENT. THE PT WAS UNDERGOING A CYSTOSCOPY WITH RIGHT "RETROGRADE" PYELOGRAM, STENT CHANGE, LEFT ANTEGRADE PYELOGRAM, AND NEPHROSTOMY CHANGE. NO HARM TO PT NOTED.

    Additional Manufacturer Narrative · 1

    PATIENT CODE: NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. DEVICE CODED: SCRATCHED MATERIAL, COIL, UNRAVELED IS NOT LABELED. 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 REPORTED WHILE USING THE AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE, THE COATING IS SCRATCHED OFF AND NOW THE OUTER COIL IS UNRAVELING. ALSO, THE INNER PART OF THE WIRE IS POKING OUT. ANOTHER DEVICE (UNKNOWN MAKE AND MANUFACTURER) WAS OPENED AND USED TO COMPLETE THE PROCEDURE. AS REPORTED, THERE WAS NO UNINTENDED PART OF THE DEVICE LEFT IN THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED EVENT. ADDITIONAL EVENT DETAILS HAVE BEEN REQUESTED; HOWEVER, NO INFORMATION HAS BEEN FORTHCOMING AT THE TIME OF THIS REPORT. THE INSTRUCTIONS FOR USE (IFU) THAT ACCOMPANIES THIS DEVICE PROVIDES THE FOLLOWING PRECAUTION: ¿ WHEN USING WIRE GUIDE THROUGH A METAL CANNULA/NEEDLE, USE CAUTION AS DAMAGE MAY OCCUR TO OUTER COATING. THE IFU'S HOW SUPPLIED SECTION ALSO INSTRUCTS: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743118 AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY COOK INC 8935584 00827002535671

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR