BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-J FIXED CORE WIRE GUIDE

    MDR report key: 20092107 · Received August 28, 2024

    Report

    Report Number
    1820334-2024-01135
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Report Date
    November 22, 2024
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002005297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: CUSTOMER (PERSON): POSTAL CODE: (B)(6); PHONE: (B)(6); MOBILE: (B)(6). E3: OCCUPATION: FACILITY MANAGER. G4: PMA/510(K) #: 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. 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 UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION IT WAS REPORTED THAT A SAFE-T-J FIXED CORE WIRE GUIDE UNRAVELED. PRIOR TO PATIENT CONTACT, THE PURPLE WIRE GUIDE STRAIGHTENER WAS USED TO AID WIRE ADVANCEMENT INTO THE NEEDLE; HOWEVER, WHEN THE STRAIGHTENER WAS MOVED, THE COIL UNRAVELED, AND THE MANDREL POKED UP. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING COMPLAINT HISTORY AND DEVICE HISTORY RECORD 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 SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WAS ONE OTHER COMPLAINT ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER FOR AN UNRELATED FAILURE. COOK ALSO REVIEWED PRODUCT LABELING: THE PRODUCT IFU, T_FCWG_REV2 ¿SAFE-T-J FIXED CORE WIRE GUIDE¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿PRECAUTIONS¿ ¿INSPECT THE WIRE GUIDE FOR KINKS AND DAMAGE PRIOR TO USE.¿ ¿HOW SUPPLIED¿ ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ EVIDENCE GATHERED UPON REVIEW THE DMR, IFU AND DHR SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE REPORTED EVENT. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. 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

    IT WAS REPORTED THAT A SAFE-T-J FIXED CORE WIRE GUIDE UNRAVELED. PRIOR TO PATIENT CONTACT, THE PURPLE WIRE GUIDE STRAIGHTENER WAS USED TO AID WIRE ADVANCEMENT INTO THE NEEDLE; HOWEVER, WHEN THE STRAIGHTENER WAS MOVED, THE COIL UNRAVELED, AND THE MANDREL POKED UP. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    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
    191130 SAFE-T-J FIXED CORE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G00529 15996273 00827002005297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown