BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE

    MDR report key: 15564186 · Received October 7, 2022

    Report

    Report Number
    1820334-2022-01605
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 6, 2022
    Report Date
    January 17, 2023
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002012530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION, ASSUMING THAT "BROKEN" REFERS TO SEPARATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. PMA/510(K) NUMBER = K171764. 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

    EVENT SUMMARY: AS REPORTED, THE TIP OF A SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE WAS "BROKEN". INVESTIGATION ¿ EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT LOT SHOWED ONE RELEVANT NONCONFORMANCE FOR 20 DEVICES THAT THE COIL TENSION WAS UNSATISFACTORY; HOWEVER, ALL NONCONFORMING DEVICES WERE SCRAPPED, AND THE LOT IS INSPECTED 100%. A DATABASE SEARCH FOR COMPLAINTS REPORTED ON THE COMPLAINT LOT REVEALED NO ADDITIONAL COMPLAINTS AT THIS TIME. THEREFORE, COOK DETERMINED THAT NO NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. ADDITIONALLY, A REVIEW OF OUR MANUFACTURING RECORDS FOR THIS DEVICE SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE DEVICE IS PROVIDED WITH INSTRUCTIONS FOR USE WHICH STATE, ¿HOW SUPPLIED: UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." THE IFU ALSO CAUTIONS, ¿USE MEDICAL IMAGING WHEN YOU MANIPULATE THE WIRE GUIDE. DO NOT ADVANCE OR MANIPULATE THE WIRE GUIDE WITHOUT VISUAL EVIDENCE OF THE CORRESPONDING MOVEMENT OF THE DISTAL TIP. DO NOT ADVANCE OR WITHDRAW A WIRE GUIDE WHEN RESISTANCE IS ENCOUNTERED, AS A PERFORATION COULD OCCUR. INSPECT THE WIRE GUIDE FOR KINKS OR DAMAGE PRIOR TO USE.¿ BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE OF THE FAILURE COULD NOT BE ESTABLISHED. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER A REVIEW OF RISK DOCUMENTATION, NO FURTHER ACTION IS REQUIRED. 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

    AS REPORTED, THE TIP OF A SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE WAS "BROKEN". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592593 SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G01253 14697904 00827002012530

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown