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

Model Number	G34783
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when unpacking the guardia access embryo transfer catheter, the inner catheter packaging was found damaged prior to an embryo transfer procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Device did not make patient contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.E1: customer street = (b)(6).Postal code = (b)(6).E3: occupation = unknown.Investigation ¿ evaluation: as reported, when unpacking the guardia access embryo transfer catheter, the inner catheter packaging was found damaged prior to an embryo transfer procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Device did not make patient contact.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control as well as a visual inspection of the returned device, were conducted during the investigation.The guardia access embryo transfer catheter was returned for evaluation.A visual inspection noted a hole in the poly portion of the inner bag.A review of relevant manufacturing documents was conducted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other complaints associated with the reported device lot.Review of the device history record, complaint history, quality control documents, and device failure analysis indicates that the device was manufactured out of specification but does not suggest items in the lot or similar devices in the field or in house are nonconforming.Cook also reviewed product labeling.The product ifu, ¿embryo transfer catheter¿ does not provide any information to the user related to the reported failure mode.Based on the information provided, inspection of the returned device, and the results of the investigation, the issue is most likely attributed to the packaging operator placing the device too low on the sealer, and the product protector getting caught in the end seal area, tearing the package.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: 19929199
• Report Number: 1820334-2024-01053
• Device Sequence Number: 14134514
• Product Code: MQF
• UDI-Device Identifier: 00827002347830
• UDI-Public: (01)00827002347830(17)260515(10)15438481
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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 Expiration Date: 05/15/2026
• Device Model Number: G34783
• Device Catalogue Number: K-JETS-7019
• Device Lot Number: 15438481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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 Sex: Unknown