BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL WIRE GUIDE

    MDR report key: 13637691 · Received March 1, 2022

    Report

    Report Number
    1820334-2022-00323
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    January 23, 2022
    Report Date
    November 14, 2022
    Manufacturer
    COOK INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT # - POSSIBLE LOT NUMBER 13906675. 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. 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, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION. ON 14FEB2022, COOK WAS INFORMED BY VIRGINIA COMMONWEALTH UNIVERSITY HOSPITAL (UNITED STATES) A TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL WIRE GUIDE (RPN:STF-18-40-AUST; LOT #: UNKNOWN) UNRAVELED IN AN UNKNOWN PATIENT DURING A CENTRAL LINE PLACEMENT PROCEDURE IN THE PICU. ON 23JAN2022, A CENTRAL VENOUS LINE WAS BEING PLACED IN A PATIENT FOR THE ADMINISTRATION OF VASOPRESSORS. THE WIRE WAS INSERTED THROUGH THE CENTRAL LINE AND NO OTHER NEEDLES WERE INVOLVED. UPON REMOVAL, THE 18G WIRE UNCOILED INSIDE OF THE PATIENT. THE ATTENDING PHYSICIAN WAS NOTIFIED AND LATER REMOVED THE WIRE FROM THE PATIENT WITHOUT FURTHER INTERVENTION. AFTER ATTEMPTS WITH MULTIPLE WIRES, THE LINE PLACEMENT WAS ULTIMATELY UNSUCCESSFUL. IT WAS CONFIRMED THAT THE WIRE WAS NOT ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY ABNORMAL ANATOMY. THE ORIGINAL PACKAGE WAS NOT SAVED BUT THE REMAINING PRODUCT OF THE SAME RPN WERE FROM THE LOT NUMBER 13906675. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. REVIEWS OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL PROCEDURES, AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED OF THE COMPLAINT DEVICE. 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 DHR FOR THE RELATED COMPLAINT DEVICE LOT 13906675 CONTAINED ONE RELEVANT NON-CONFORMANCE. THE RELEVANT NON-CONFORMANCE IS FOR THREE BEING SCRAPPED DUE TO INSUFFICIENT SOLDER. THE RELATED SUBASSEMBLY LOTS DID NOT HAVE ANY NON-CONFORMANCES. THERE ARE NO ADDITIONAL COMPLAINTS ON THIS LOT. THERE IS NO EVIDENCE OF NON-CONFORMING MATERIAL IN HOUSE OR IN THE FIELD. THIS PRODUCT IS 100% INSPECTED FOR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. COOK ALSO REVIEWED PRODUCT LABELING. THIS PRODUCT IS SUPPLIED WITH AN IFU PAMPHLET T_MWG_REV0. IN THE WARNING SECTION IS STATES: 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. IN THE PRECAUTIONS SECTION IT STATES: WHEN YOU USE THE WIRE GUIDE WITH ANOTHER DEVICE, CONSIDER THE END-HOLE SIZE AND THE LENGTH OF THE DEVICE TO ENSURE A PROPER FIT BETWEEN THE WIRE GUIDE AND THE DEVICE. IN THE INSTRUCTIONS FOR USE SECTION, IT STATES: 1.) FLUSH THE WIRE GUIDE HOLDER BY ATTACHING A SYRINGE WITH HEPARINIZED SALINE OR STERILE WATER TO THE FITTING OF THE WIRE GUIDE HOLDER. INJECT ENOUGH SOLUTION TO WET THE WIRE SURFACE ENTIRELY. 2.) CAREFULLY REMOVE THE WIRE GUIDE FROM THE HOLDER. 3.) IF NEEDED, INSERT 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 INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, THE MOST LIKELY CAUSE FOR THIS FAILURE IS COMPONENT FAILURE. 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

    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 TORQ-FLEX (B)(6) MODIFICATION MANDRIL WIRE GUIDE UNRAVELED IN AN UNKNOWN PATIENT DURING A CENTRAL LINE PLACEMENT PROCEDURE IN THE PICU. A CENTRAL VENOUS LINE WAS BEING PLACED IN A PATIENT FOR THE ADMINISTRATION OF VASOPRESSORS. AT AN UNKNOWN TIME DURING THE PROCEDURE, THE 18G WIRE UNCOILED INSIDE OF THE PATIENT. THE ATTENDING PHYSICIAN WAS NOTIFIED AND LATER REMOVED THE WIRE FROM THE PATIENT WITHOUT FURTHER INTERVENTION. AFTER ATTEMPTS WITH MULTIPLE WIRES, THE LINE PLACEMENT WAS ULTIMATELY UNSUCCESSFUL. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY ABNORMAL ANATOMY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE PROLONGED HOSPITALIZATION 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 11APR2022 AND 14APR2022. IT WAS REPORTED THAT THE WIRE BEGAN TO UNRAVEL UPON REMOVAL. IT WAS CONFIRMED THAT THE WIRE WAS NOT ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE. THE WIRE WAS INSERTED THROUGH THE CENTRAL LINE AND NO OTHER NEEDLES WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794222 TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown