BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL WIRE GUIDE

    MDR report key: 13256230 · Received January 13, 2022

    Report

    Report Number
    1820334-2022-00055
    Event Type
    Injury
    Date Received
    January 13, 2022
    Date of Event
    October 22, 2021
    Report Date
    October 25, 2022
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION: RISK MANAGER. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION A REPRESENTATIVE OF (B)(6) HOSPITAL REPORTED ON 22OCT2021 VIA A MEDWATCH THAT A TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL WIRE GUIDE (RPN: STF-18-60-AUST, LOT# UNKNOWN) SEPARATED. THE DEVICE WAS REQUIRED FOR A PICC LINE PLACEMENT PROCEDURE PERFORMED UNDER FLUOROSCOPY. THE WIRE WAS NOT MODIFIED FROM ITS ORIGINAL CONDITION PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE CATHETER WAS ADVANCED WITH NO DIFFICULTY INTO THE PATIENT VIA THE RIGHT BASILIC VEIN. THE WIRE GUIDE WAS REMOVED WITH DIFFICULTY, AND SEPARATION OCCURRED. AS A RESULT, THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE WITH ANESTHESIA TO SUCCESSFULLY RETRIEVE THE WIRE GUIDE FRAGMENT. THE PATIENT DID NOT EXPERIENCE HOSPITALIZATION OR PROLONGED HOSPITALIZATION, AND NO OTHER ADVERSE EVENTS WERE REPORTED DUE TO THIS OCCURRENCE. A REVIEW OF COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS (MI), SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES WERE 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. 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 CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICES. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: PER IFU T_MWG_REV0: ¿WARNINGS¿ THIS PRODUCT IS A DELICATE INSTRUMENT. AVOID FORCEFUL ANGULATION. AVOID MANIPULATING OR WITHDRAWING THE WIRE GUIDE BACK THROUGH A METAL NEEDLE OR CANNULA. A SHARP EDGE MAY SCRAPE OR SHEAR MATERIAL FROM THE WIRE GUIDE¿ EXCESSIVE TIGHTENING OF A TORQUE DEVICE MAY ABRADE THE COATING ON THE WIRE GUIDE¿ INSTRUCTIONS FOR USE¿ 1. FLUSH THE WIRE GUIDE HOLDER¿ 2. CAREFULLY REMOVE THE WIRE GUIDE FROM THE HOLDER. 3. IF NEEDED, INSERT A WIRE GUIDE INSERTION TOOL (PROVIDED)¿ 4. ATTACH A TORQUE DEVICE TO THE WIRE GUIDE (IF PROVIDED). 5. STANDARD WIRE GUIDE TECHNIQUES MAY NOW BE EMPLOYED¿ HOW SUPPLIED¿ UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED THE ROOT CAUSE WAS COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FRAGMENT OF A TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL WIRE GUIDE BROKE OFF DURING REMOVAL FOLLOWING THE PLACEMENT OF A PICC LINE IN AN UNKNOWN PATIENT. THE FRAGMENT WAS COMPLETELY REMOVED IN AN ADDITIONAL PROCEDURE UNDER ANESTHESIA. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

    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.

    Description of Event or Problem · 0

    IN ADDITIONAL INFORMATION RECEIVED ON 24JAN2022, IT WAS REPORTED THAT THE PICC LINE PLACEMENT PROCEDURE WAS COMPLETED UNDER FLUOROSCOPY, WITH THE ACCESS SITE AND TARGET LOCATION BEING IN THE RIGHT UPPER EXTREMITY/RIGHT BASILIC VEIN. THE PATIENT DID NOT HAVE TORTUOUS, CALCIFIED OR SCARRED ANATOMY. IT WAS REPORTED THAT THERE WAS NO DIFFICULTY EXPERIENCED DURING WIRE ADVANCEMENT, HOWEVER THERE WAS DIFFICULTY NOTED WHEN REMOVING THE WIRE. THE WIRE WAS NOT MODIFIED FROM ITS ORIGINAL CONDITION PRIOR TO THE PROCEDURE. IT WAS CONFIRMED THAT THE WIRE FRAGMENT WAS REMOVED WITHOUT INCIDENT IN AN ADDITIONAL PROCEDURE. THE PATIENT DID NOT EXPERIENCE HOSPITALIZATION OR PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833734 TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Required Intervention