MAUDE Adverse Event Report: COOK INC SOFT-PASS EMBRYO TRANSFER CATHETER SET; ASSISTED REPRODUCTION TRANSFER CATHETER/SET

Model Number	G17934
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	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, after opening the package of a soft-pass embryo transfer catheter set a hair was discovered on one of the transfer catheters.The issue was discovered prior to patient contact and the device was not used.The complainant has not reported any adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
H3: 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
Additional information was received 09jun2025 indicating the complaint device will not be returned for investigation.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information/correction: d9 - device will not be returned.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
It was reported, after opening the package of a soft-pass embryo transfer catheter set a hair was discovered on one of the transfer catheters.The issue was discovered prior to patient contact and the device was not used.The complainant has not reported any adverse effects on the patient due to this occurrence.Reviews of documentation including the complaint history, quality control procedures, manufacturing instructions (mi), and instructions for use (ifu) were conducted during the investigation.The product was not returned.There was one photo provided by the customer showing a small hair like fiber stuck between the guide catheter and product protector.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 dhrs for the reported complaint device lot revealed one similar non-conformance in which three devices were scrapped.A complaint review revealed this be the only complaint associated with the complaint device lot.The information provided upon review of the dmr, dhr, ifu, and complaint file suggests that there is evidence the device was manufactured out of specification.There is no evidence of non-conforming devices in-house or in the field.However, cook has concluded that this issue is an isolated incident, and there is no evidence of additional nonconforming devices in house or out in the field.The product ifu, does not provide information for end users related to this failure mode.Based on the available information, no product returned, and the results of the investigation, the issue was due to a manufacturing deficiency.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: SOFT-PASS EMBRYO TRANSFER CATHETER SET
• Common Device Name: ASSISTED REPRODUCTION TRANSFER CATHETER/SET
• 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: 22054620
• Report Number: 1820334-2025-00564
• Device Sequence Number: 20626892
• Product Code: MQF
• UDI-Device Identifier: 00827002179349
• UDI-Public: (01)00827002179349(17)261229(10)15824725
• Combination Product (Y/N): N
• PMA/510(K) Number: K173103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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: G17934
• Device Catalogue Number: K-J-SPPE-681710
• Device Lot Number: 15824725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 08/18/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/13/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2023
• 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