BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVET GUIDE EMBRYO TRANSFER SET

    MDR report key: 17512063 · Received August 11, 2023

    Report

    Report Number
    1820334-2023-01072
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 19, 2023
    Report Date
    November 21, 2023
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002304574
    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 OR UNAVAILABLE. E1: NAME AND ADDRESS: PHONE: (B)(6). E1: NAME AND ADDRESS: POSTAL CODE: (B)(6). E3: OCCUPATION: AGENT. G4: PMA/510K # 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: AS REPORTED ON 19JUL2023, AN INCIDENT OCCURRED INVOLVING A 'PIVET GUIDE EMBRYO TRANSFER SET'. AS REPORTED, DURING AN EMBRYO TRANSFER, THE TRANSFER CATHETER COULD NOT BE PUSHED THROUGH THE GUIDE CATHETER DUE TO FOREIGN MATTER IN/ON THE DEVICE. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE DEVICE SET WAS RETURNED. THE DEVICES WERE COVERED AND FILLED IN A RED SUBSTANCE THAT RESEMBLED BIOMATTER. THE DEVICES WERE RINSED AND THE SUBSTANCE WAS REMOVED. THE TRANSFER CATHETER WAS ABLE TO COMPLETELY ENTER AND EXIT THE GUIDE CATHETER WITH NO ISSUES AFTER THE SUBSTANCE WAS REMOVED. ADDITIONALLY, 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 SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR DEVICE LOT RECORDS NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, AND QUALITY CONTROL DOCUMENTS DID NOT PROVIDE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION OR TO SUGGEST ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE WERE NONCONFORMING. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, 'EMBRYO TRANSFER CATHETER', PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: "BLEEDING MAY OCCUR AS A RESULT OF TRAUMA DUE TO INSERTION OF THE CATHETER THROUGH THE CERVIX." BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THIS EVENT IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE. IT IS MOST LIKELY BIOMATTER THAT ENTERED THE DEVICE AS IT WAS INSERTED INSIDE THE PATIENT. THE BIOMATTER OCCLUDED THE GUIDE CATHETER CAUSING THE DIFFICULT TRANSITION OF THE TRANSFER CATHETER. 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

    AS REPORTED, DURING AN EMBRYO TRANSFER USING A PIVET GUIDE EMBRYO TRANSFER SET, THE TRANSFER CATHETER COULD NOT BE PUSHED THROUGH THE GUIDE CATHETER DUE TO FOREIGN MATTER IN/ON THE DEVICE. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    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
    762096 PIVET GUIDE EMBRYO TRANSFER SET MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC N/A 15064406 00827002304574

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female