BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPE NITINOL MANDRIL WIRE GUIDE

    MDR report key: 12299809 · Received August 10, 2021

    Report

    Report Number
    1820334-2021-01947
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    August 4, 2021
    Report Date
    November 3, 2021
    Product Code
    DQX
    UDI-DI
    00827002084278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION C.H.R.U. DE CAEN IN FRANCE CONTACTED COOK STATING THAT DURING A LIVER ACCESS PROCEDURE, A PMG-18SP-60-COPE-NT FROM LOT# 13956172 BROKE OFF AND A FRAGMENT WAS LOST INSIDE THE PATIENT. THE FRAGMENT WAS ABLE TO BE RETRIEVED VIA A SNARE. THE PATIENT DID NOT HAVE TORTUOUS ANATOMY AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE ARE PROCESS CHECKS DURING THE MANUFACTURING PROCESS TO IDENTIFY NON-CONFORMANCES PRIOR TO DISTRIBUTION. THIS DEVICE IS SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) T_MWG_REVO PAMPHLET. UNDER HOW SUPPLIED, IT STATES: "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." THIS IFU ALSO PROVIDES A WARNING THAT THIS IS A DELICATE INSTRUMENT AND TO AVOID FORCEFUL ANGULATION. THE PRODUCT LABELING GIVES THE PRECAUTION TO USE MEDICAL IMAGING WHEN MANIPULATING THE WIRE GUIDE. DO NOT ADVANCE OR TORQUE THE WIRE GUIDE WITHOUT VISUAL EVIDENCE OF THE CORRESPONDING MOVEMENT OF THE DISTAL TIP. THIS WIRE GUIDE IS SUPPLIED WITH A HOLDER THAT COMES WITH A CAUTION LABEL STATING NOT TO WITHDRAW THE WIRE GUIDE THROUGH A NEEDLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION TO CHECK FOR FAILURE-RELATED NONCONFORMANCES AND ADDITIONAL COMPLAINTS. THE DHR FOR THE COMPLAINT LOT FOUND ONE RELEVANT NONCONFORMANCE. THE NON-CONFORMANCE CONSISTED OF THREE SCRAPPED DEVICES FOR THE COIL BEING OFFSET, AND THERE IS A 100% INSPECTION FOR THIS FAILURE. THERE ARE NO ADDITIONAL COMPLAINTS FOR THIS LOT. THERE IS NO EVIDENCE OF NON-CONFORMING MATERIAL IN HOUSE OR IN THE FIELD. THERE IS NO EVIDENCE OF MANUFACTURING DEFICIENCIES. BASED ON THE INFORMATION PROVIDED, THE COMPLAINT DEVICE NOT BEING RETURNED, AND THE RESULTS OF THE INVESTIGATION, THE MOST LIKELY CAUSE FOR THIS FAILURE IS COMPONENT FAILURE WITHOUT A DESIGN OR MANUFACTURING ISSUE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    IN ADDITIONAL INFORMATION PROVIDED ON 29SEP2021, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. IT WAS NOTED THAT THE WIRE GUIDE WAS NOT MANIPULATED THROUGH A NEEDLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K171997. 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 THAT A COPE NITINOL MANDRIL WIRE GUIDE SEPARATED. AN UNKNOWN PATIENT WAS UNDERGOING A LIVER ACCESS PROCEDURE. DURING THE PROCEDURE, THE WIRE GUIDE SEPARATED. A PORTION OF THE DEVICE MIGRATED IN TO THE BILE DUCT DURING PERCUTANEOUS DRAINAGE. THE DEVICE WAS REPORTED AS "LOST" IN THE PATIENT'S BODY BUT WAS RETRIEVED WITH A SNARE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200343 COPE NITINOL MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX N/A 13956172 00827002084278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention