BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPE MANDRIL WIRE GUIDE

    MDR report key: 15112802 · Received July 27, 2022

    Report

    Report Number
    1820334-2022-01283
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    May 13, 2022
    Report Date
    February 13, 2023
    Manufacturer
    COOK INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER OCCUPATION: NURSE MANAGER, INTERVENTIONAL SERVICES/ NON-INVASIVE CARDIAC TESTING. 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

    CORRECTION: F10/H10: ANNEX E, ANNEX F, 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

    INVESTIGATION ¿ EVALUATION: (B)(6) HOSPITAL (UNITED STATES) CONTACTED COOK ON 15JUL2022 CONCERNING A COPE MANDRIL WIRE GUIDE (RPN: PMG-18SP-60-COPE; LOT #: UNKNOWN). ON (B)(6) 2022, AN UNKNOWN PATIENT UNDERWENT A PICC LINE PLACEMENT PROCEDURE. THE CUSTOMER STATED THAT WHEN THEY ADVANCED THE WIRE GUIDE THROUGH AN EIGHTEEN-GAUGE NEEDLE, IMAGING SHOWED WHAT APPEARED TO BE A FRAYED WIRE. WHEN THE WIRE GUIDE WAS REMOVED FROM THE NEEDLE, THE WIRE GUIDE WAS NOTED TO BE FRAYED. NO PART OF THE PRODUCT REMAINED WITHIN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES FOR THE DEVICE, 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. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT THERE ARE PROCEDURES IN PLACE TO PREVENT THIS NON-CONFORMANCE FROM LEAVING HOUSE. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A SALES REPORT WAS PERFORMED. DUE TO THE QUANTITY OF POSSIBLE LOT NUMBERS, IT WAS NOT POSSIBLE TO PERFORM A DEVICE HISTORY RECORD FOR THIS COMPLAINT. BASED ON THE INFORMATION PROVIDED AND THE INFORMATION FROM INVESTIGATION, COOK WAS NOT ABLE TO DETERMINE THE PRODUCT OUT OF SPECIFICATION. COOK WAS NOT ABLE TO DETERMINE NON-CONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THIS PRODUCT IS SUPPLIED WITH AND INSTRUCTIONS FOR USE (IFU) PAMPHLET, T_MWG_REV0. IN THE WARNINGS SECTION IT STATES: "THIS PRODUCT IS A DELICATE INSTRUMENT. AVOID FORCEFUL ANGULATION. AVOID MANIPULATING OR WITHDRAWING THE SIRE 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: USE MEDICAL IMAGING WHEN YOU MANIPULATE THE WIRE GUIDE. DO NOT ADVANCE OR TORQUE THE WIRE GUIDE WITHOUT VISUAL EVIDENCE OF THE CORRESPONDING MOVEMENT OF THE DISTAL TIP. IN THE INSTRUCTIONS FOR USE SECTION, IT STATES: 3.) IF NEEDED, INSERT A 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. 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 RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, THIS FAILURE IS DETERMINED TO BE UNINTENDED USER ERROR. THERE ARE INSTRUCTIONS PROVIDED TO NOT MANIPULATE OR WITHDRAW THE WIRE GUIDE THROUGH THE NEEDLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF A COPE MANDRIL WIRE GUIDE BECAME UNRAVELED DURING A PROCEDURE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON 28JUL2022:. A PICC LINE WAS BEING PLACED IN A PATIENT IN INTERVENTIONAL RADIOLOGY (IR). ACCESS (DESCRIBED AS DIFFICULT) WAS OBTAINED USING ULTRASOUND. AN 18 GAUGE NEEDLE WAS USED AND A 0.018 COPE WIRE GUIDE WAS ADVANCED INTO THE ACCESS SITE. THE EVENT OCCURRED DURING INSERTION. THE PHYSICIAN'S ASSISTANT (PA) INSERTED THE COPE WIRE INTO THE 18 G NEEDLE AND WHEN THEY REIMAGED THEY SAW WHAT LOOKED LIKE A FRAYED WIRE. THE NOTE IN THE PATIENT'S CHART STATES "¿COPE WIRE FRAYED WHEN IT WAS REMOVED THROUGH THE MICROPUNCTURE NEEDLE.¿ NO FRAGMENTS WERE REPORTED TO HAVE BEEN RETAINED INSIDE THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED. NO ADVERSE EFFECTS OR HOSPITALIZATION WAS REQUIRED.

    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
    2431269 COPE MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 18 GAUGE NEEDLE