BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPE NITINOL MANDRIL WIRE GUIDE

    MDR report key: 15691891 · Received October 28, 2022

    Report

    Report Number
    1820334-2022-01663
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    July 22, 2022
    Report Date
    April 27, 2023
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: IT WAS REPORTED BY (B)(6) HOSPITAL- DENVILLE (USA) THAT A COPE NITINOL MANDRIL WIRE GUIDE (RPN: PMG-18SP-60-COPE-NT; LOT# UNKNOWN) SEPARATED. THE PATIENT PRESENTED WITH STROKE RELATED TO BASILAR ARTERY OCCLUSION. HE WAS OUTSIDE THE TREATMENT WINDOW FOR TISSUE PLASMINOGEN ACTIVATOR (TPA; A CLOT-DISSOLVING MEDICATION) ADMINISTRATION; THEREFORE, A MECHANICAL THROMBECTOMY WITH REPERFUSION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, WHEN THE WIRE GUIDE WAS REMOVED FROM THE PATIENT, APPROXIMATELY 1.5MM OF THE TIP SEPARATED AND WAS RETAINED OUTSIDE THE ARTERY IN THE PATIENT'S SOFT TISSUE. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT PROCESS STEPS WERE IDENTIFIED TO ENSURE THIS FAILURE MODE DOES NOT LEAVE HOUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED DUE TO THE LACK OF LOT INFORMATION PROVIDED. COOK ALSO REVIEWED PRODUCT LABELING. THIS PRODUCT IS SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET, T_MWG_REV0. IN THE PRECAUTIONS SECTION IT STATES: USE MEDICAL IMAGING WHEN YOU MANIPULATE THE WIRE GUIDE. DO NOT ADVANCE OR TORQUE THE WIRE GUIDE WITHOUT VISUAL EVIDENCE OF THE CORRESPONDING MOVEMENT OF THE DISTAL TIP. WHEN YOU USE THE WIRE GUIDE WITH ANOTHER DEVICE, CONSIDER THE END-HOLE SIZE AND THE LENGTH OF THE DEVICE IN ORDER TO ENSURE A PROPER FIT BETWEEN THE WIRE GUIDE AND THE DEVICE. IN THE INSTRUCTIONS FOR USE SECTION, IT STATES: 3.) IF NEEDED, INSERT THE WIRE GUIDE INSERTION TOOL (PROVIDED) THROUGH THE VALVE ASSEMBLY OR HUB OF THE GUIDING SHEATH OR OTHER INTERVENTIONAL DEVICE. INSERT THE TIP OF THE WIRE GUIDE THROUGH THE INSERTION TOOL AND ADVANCE THE WIRE GUIDE TO THE DESIRED LOCATION. 4.) ATTACH A TORQUE DEVICE TO THE WIRE GUIDE (IF PROVIDED). 5.) STANDARD WIRE GUIDE TECHNIQUES MAY NOW BE EMPLOYED. IN THE HOW SUPPLIED SECTION IT STATES: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE DMR, THE INABILITY TO REVIEW THE DHR, AND WITH NO PRODUCT RETURN, COOK CANNOT DETERMINE IF THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION. COOK WAS NOT ABLE TO DETERMINE IF ANY NONCONFORMING MATERIAL REMAINS IN HOUSE OR IN THE FIELD. FROM THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE CONTRIBUTED TO THE REPORTED EVENT. IT IS POSSIBLE THAT THE PRODUCT WAS DAMAGED DUE TO THE OVER MANIPULATION OF THE WIRE GUIDE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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

    IT WAS REPORTED THAT A COPE NITINOL MANDRIL WIRE GUIDE SEPARATED DURING A MECHANICAL THROMBECTOMY WITH REPERFUSION PROCEDURE. WHEN THE WIRE GUIDE WAS REMOVED FROM THE PATIENT, APPROXIMATELY 1.5MM OF THE TIP SEPARATED AND WAS RETAINED IN THE PATIENT'S SOFT TISSUE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2868233 COPE NITINOL MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Other