BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER

    MDR report key: 12664605 · Received October 20, 2021

    Report

    Report Number
    1820334-2021-02354
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    September 23, 2021
    Report Date
    February 7, 2022
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002347830
    PMA / PMN Number
    K173686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. DESCRIPTION OF EVENT: AS REPORTED, WHILE ATTEMPTING TO USE A GUARDIA ACCESS EMBRYO TRANSFER CATHETER, FOREIGN MATTER WAS NOTED IN THE TRANSFER CATHETER AND WAS UNABLE TO PASS THROUGH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. COMPLAINT DEVICE RECEIVED IN OPEN PACKAGING. CONSIDERABLE AMOUNT OF BIOMATTER PRESENT ON BOTH CATHETERS. COULD NOT SEE INTO TRANSFER CATHETER THROUGH MATTER. DEVICE ALSO BENT INTO CURVE. MATTER NOTED INSIDE TRANSFER CATHETER. UNSURE OF ORIGIN AND WHETHER ITS DRIED MEDIA. PICTURES TAKEN; ASPIRATION TEST WAS ABLE TO BE CONDUCTED ALBEIT WITH BUBBLES AND MEDIA FRACTURE. A 0.018 WIRE GUIDE WAS PASSED THROUGH TC. DINO PICS WERE TAKEN OF THE WIRE GUIDE ONCE IT EMERGED FROM THE END OF THE TC SHOWED A TRANSPARENT RING-LIKE MATTER ON THE END OF THE WIREGUIDE, WHICH PRESUMABLY ORIGINATED IN THE TRANSFER CATHETER. UNABLE TO EXAMINE RING-LIKE MATTER ONCE IT WAS REMOVED FROM THE WIRE. GUIDE CATHETER HAD A FEW SPOTS WHERE DRIED MEDIA WAS VISIBLE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: NOTE: ONE CELL MEA TESTED AND PASSED WITH 80% OR GREATER BLASTOCYST DEVELOPMENT WITHIN 96 HRS. USP ENDOTOXIN (LAL) TESTED AND PASSED WITH 20 EU OR LESS PER DEVICE. HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. ASPIRATION TEST REVEALED THE TRANSFER CATHETER WAS OCCLUDED WITH AN UNIDENTIFIED SUBSTANCE CLEAR IN COLOR. CONTROLS ARE IN PLACE TO ASSURE THE TUBING IS NOT OCCLUDED PRIOR TO DISTRIBUTION. THERE WERE NO RELATED NONCONFORMANCES OR COMPLAINTS. SINCE THE DEVICE WAS RETURNED IN POTENTIALLY USED CONDITION, IT IS POSSIBLE THE OCCLUSION IS A RESULT OF THE PRODUCTS USED BY THE USER FACILITY TO ASPIRATE THE DEVICE. THEREFORE, A DEFINITIVE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    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

    AS REPORTED, WHILE ATTEMPTING TO USE A GUARDIA ACCESS EMBRYO TRANSFER CATHETER, FOREIGN MATTER WAS NOTED IN THE TRANSFER CATHETER AND WAS UNABLE TO PASS THROUGH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566253 GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC G34783 13593419 00827002347830

    Patients

    Seq Age Sex Outcome Treatment
    1 Female