MAUDE Adverse Event Report: COOK INC GUARDIA ACCESS EMBRYO TRANSFER CATHETER; MQF CATHETER, ASSISTED REPRODUCTION

Model Number	G34783
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4 - weight: 60.5 kg a5 - ethnicity: chinese h3 - device evaluated by mfg: device evaluation anticipated, but not yet begun.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.
Event or Problem Description
As reported, during embryo transfer (ivf) procedure, an unspecified protruding foreign body was identified upon microscopic examination on the inner wall of the outer 'guardia access embryo transfer catheter'.This issue was discovered when the clinical instructor observed that the inner catheter could not pass through the outer catheter.The procedure was completed successfully using a new outer catheter.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to this event.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: as reported, during embryo transfer (ivf) procedure, an unspecified protruding foreign body was identified upon microscopic examination on the inner wall of the outer 'guardia access embryo transfer catheter'.This issue was discovered when the clinical instructor observed that the inner catheter could not pass through the outer catheter.The procedure was completed successfully using a new outer catheter.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to this event.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.Functional tests and visual inspection of the returned complaint device was also conducted.Only one guide catheter was returned for investigation in a sealed inner pouch.After removing from the sealed package, a wire was able to pass completely through the guide catheter.No foreign matter was noted.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) found no confirmed relevant discrepancies on the lot.A search of complaint history found no related complaints on the lot.Because adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and based on review of complaints from associated with the product lot, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu supplied with the device did not provide any information related to the reported issue.Based upon the available information, inspection of the returned device, and results of the investigation, cook has concluded that the cause for the complaint could not be established.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.

• Brand Name: GUARDIA ACCESS EMBRYO TRANSFER CATHETER
• Common Device Name: MQF CATHETER, ASSISTED REPRODUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 23877369
• Report Number: 1820334-2025-01598
• Device Sequence Number: 15854331
• Product Code: MQF
• UDI-Device Identifier: 00827002347830
• UDI-Public: (01)00827002347830(17)271103(10)16323771
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K173686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G34783
• Device Catalogue Number: K-JETS-7019
• Device Lot Number: 16323771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Race: Asian