BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENTSON STRAIGHT FIXED CORE WIRE GUIDE

    MDR report key: 19458734 · Received June 4, 2024

    Report

    Report Number
    1820334-2024-00760
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Report Date
    August 12, 2024
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002012905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E3: CLINICAL SUPPORT SERVICES COORDINATOR. 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 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: IT WAS REPORTED TO COOK THAT TWO BENTSON STRAIGHT FIXED CORE WIRE GUIDES UNRAVELED. DURING REMOVAL, WHEN THE CLINICIAN PULLED THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE BACK TO STRAIGHTEN OUT THE TIP, THE WIRE GUIDE UNRAVELED INSIDE THE ANGIOGRAPHIC CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT WIRE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION: D9, H3: ADDITIONAL INFORMATION WAS RECEIVED 17JUL2024, NOTING THAT A DEVICE WOULD BE RETURNED TO COOK. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF ONE COMPLAINT DEVICE WAS ALSO CONDUCTED. ONE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION, LODGED AND BROKEN INSIDE A COOK CATHETER. A LONG, UNKNOWN STRING-LIKE MATERIAL, MEASURING 45.5-CENTIMETERS IN LENGTH, WAS COMING OUT OF THE DISTAL TIP OF THE CATHETER, LODGED BESIDE THE WIRE GUIDE. WITH FORCE, THE WIRE AND UNKNOWN STRING WERE ABLE TO BE PULLED FROM THE CATHETER. THE ORIGIN OF THE STRING-LIKE MATERIAL IS UNKNOWN; HOWEVER, THE INVESTIGATION CONCLUDED THAT IT COULD NOT HAVE COME FROM THE CONSTRUCTION MATERIALS OF EITHER THE WIRE OR THE COOK CATHETER. PART OF THE WIRE SEPARATED DURING REMOVAL FROM THE CATHETER. THE FIRST SEPARATED SECTION WAS ELONGATED AND MEASURED 27-CENTIMETERS, WITH THE WELD-BALL INTACT. THE REMAINING SECTION WAS ELONGATED 5.5-CENTIMETERS. THE INNER MANDRIL AND SAFETY WIRE WERE EXPOSED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. THE CUSTOMER FOLLOWED RELEVANT INSTRUCTIONS IN THE IFU (INSTRUCTIONS FOR USE). A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE, UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES, CONTRIBUTED TO THIS EVENT, AS THE EXACT CONDITIONS EXPERIENCED DURING THE EVENT CANNOT BE DUPLICATED. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 TO COOK THAT TWO BENTSON STRAIGHT FIXED CORE WIRE GUIDES UNRAVELED. DURING REMOVAL, WHEN THE CLINICIAN PULLED THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE BACK TO STRAIGHTEN OUT THE TIP, THE WIRE GUIDE UNRAVELED INSIDE THE ANGIOGRAPHIC CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT WIRE. 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
    666623 BENTSON STRAIGHT FIXED CORE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G01290 16009761 00827002012905

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MIK CATHETER