BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 10277565 · Received July 15, 2020

    Report

    Report Number
    1820334-2020-01302
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    July 2, 2020
    Report Date
    September 15, 2020
    Manufacturer
    COOK INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: B5: THE COMPLAINT DEVICE WAS AN UNSPECIFIED COOK ROADRUNNER UNI-GLIDE HYDROPHYLIC WIRE GUIDE (UNKNOWN LOT, UNKNOWN RPN). D2: COMMON NAME & PRODUCT CODE = THE PRODUCT CODE FOR THE ROADRUNNER WIRE IS: DQX WIRE, GUIDE, CATHETER. G5: PMA/510(K) NUMBER = ALTHOUGH THE EXACT RPN IS UNKNOWN, THE 510(K) NUMBER FOR ROADRUNNER WIRES IS EITHER K110009 OR K130766. SUMMARY OF EVENT: IT WAS REPORTED, DURING A PAD PROCEDURE, AN UNSPECIFIED COOK MEDICAL WIRE GUIDE BEGAN TO UNRAVEL. THE PHYSICIAN WAS UNABLE TO REMOVE THE WIRE GUIDE BY PUSHING IT BACK TOGETHER OR PULLING IT THROUGH THE SHEATH. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH DIFFERENT WIRE GUIDE FROM ANOTHER MANUFACTURER. REPORTEDLY, THE WIRE DID NOT HAVE ANY KINKS, AND NO INTERVENTIONS WERE NECESSARY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS WAS CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS NOT RETURNED TO COOK FOR ANALYSIS AND THUS A DEVICE FAILURE ANALYSIS COULD NOT BE PERFORMED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. AS THE LOT NUMBER WAS NOT PROVIDED, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE DESIGN RISK ANALYSIS DOCUMENTATION FOR THIS TYPE OF WIRE STATES CURRENT RISK CONTROLS FOR THIS FAILURE INCLUDE: DESIGN VERIFICATION AND VALIDATION TESTING, PROCESS VALIDATION TESTING, THE PRODUCT IFU AND 100% QC INSPECTION PRIOR TO SHIPPING. THE PRODUCT IFU CAUTIONS: ¿AVOID MANIPULATING OR WITHDRAWING THE HYDROPHILIC WIRE GUIDE BACK THROUGH A METAL NEEDLE OR CANNULA. A SHARP EDGE MAY SCRAPE THE COATING OR SHEAR THE WIRE GUIDE. A CATHETER, INTRODUCER SHEATH OR VESSEL DILATOR SHOULD REPLACE THE NEEDLE AS SOON AS THE WIRE GUIDE HAS BEEN INSERTED IN THE VESSEL." BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ACTION 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    OCCUPATION: RT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A PAD PROCEDURE, AN UNSPECIFIED COOK MEDICAL WIRE GUIDE BEGAN TO UNRAVEL. THE PHYSICIAN WAS UNABLE TO REMOVE THE WIRE GUIDE BY PUSHING IT BACK TOGETHER OR PULLING IT THROUGH THE SHEATH. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH DIFFERENT WIRE GUIDE FROM ANOTHER MANUFACTURER. REPORTEDLY, THE WIRE DID NOT HAVE ANY KINKS, AND NO INTERVENTIONS WERE NECESSARY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744775 UNKNOWN DQX WIRE, GUIDE, CATHETER DQX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1