BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVET GUIDE EMBRYO TRANSFER SET

    MDR report key: 20181824 · Received September 10, 2024

    Report

    Report Number
    1820334-2024-01202
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 27, 2024
    Report Date
    December 18, 2024
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002304574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - NAME AND ADDRESS: POSTAL CODE: (B)(6). PHONE: (B)(6). E3 - OCCUPATION: AGENT. G4 ¿ PMA/510(K) #: K173103. 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

    CORRECTIONS: H6 (ANNEX A, ANNEX G): B5: ADDITIONAL INFORMATION RECEIVED 08DEC2024. FUNCTIONAL TESTS AND VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE WAS ALSO CONDUCTED. ONE, USED, DEVICE WAS RETURNED FOR INVESTIGATION. BASED ON THE DEVICE FAILURE ANALYSIS, EXAMINATION OF THE RETURNED DEVICE REVEALED THE GUIDE CATHETER HUB WAS OCCLUDED WITH EXCESS DEVICE MATERIAL. BASED ON THE EVIDENCE, IT APPEARS THE STEP THAT WOULD HAVE DETECTED THE GUIDE CATHETER OCCLUSION WAS MISSED DURING THE QUALITY CONTROL PROCESS. AS EACH DEVICE SET WAS INDIVIDUALLY CHECKED FOR OCCLUSION, IT IS UNLIKELY THIS ISSUE AFFECTS THE ENTIRE LOT. ADDITIONALLY, FOREIGN MATTER WAS NOTED, HOWEVER, THIS WAS ABLE TO BE PUSHED OUT OF THE CATHETER. UPON EXAMINATION OF THE FOREIGN MATTER, IT WAS FOUND TO BE OF REDDISH COLOR, CONSISTENT WITH BIOMATTER. ADDITIONAL INFORMATION WAS REQUESTED TO CONFIRM IF THE DEVICE DID COME INTO CONTACT WITH THE PATIENT AND IT WAS CONFIRMED THAT THE DEVICE DID COME INTO CONTACT WITH THE PATIENT. BASED ON THIS INFORMATION, THE MATTER HAS BEEN DETERMINED TO BE DRIED BIOMATTER, WHICH IS NOT CONSIDERED 'FOREIGN MATTER', THEREFORE, THIS COMPLAINT IS NO LONGER CONSIDERED REPORTABLE. 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 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, BEFORE ASPIRATING THE EMBRYO, THE USER CHECKED THAT THE OUTER PACKAGE OF THE PIVET GUIDE EMBRYO TRANSFER SET WAS INTACT AND THERE WAS NO OBVIOUS DAMAGE. HOWEVER, WHEN THE USER DISASSEMBLED THE WHITE OUTER TUBE OF THE PIVET GUIDE EMBRYO TRANSFER SET, AND PREPARED TO INSERT IT, THE USER FOUND THAT THE MOUTH OF THE WHITE OUTER TUBE WAS BLOCKED AND THERE WAS OBVIOUS DIRT. SO, THE USER REPLACED IT WITH A NEW CATHETER TO SOLVE THE PROBLEM AND THE TRANSFER WENT SMOOTHLY. THE IN VITRO FERTILIZATION (IVF) EMBRYO TRANSFER PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 08DEC2024: THE CATHETER DID COME INTO CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226191 PIVET GUIDE EMBRYO TRANSFER SET MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC G30457 15787587 00827002304574

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female