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

Catalog Number	K-JETS-7019
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	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, prior to patient contact, when a 'guardia access embryo transfer catheter' was removed from the packaging, it was noted that there were plastic particles on the tip of the catheter.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer (person) postal code = (b)(6) / phone = (b)(6).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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 or that a death or serious injury occurred; nor is it admission 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
Additional information received 26jan2024: another unspecified catheter was used to complete the procedure.
Additional Manufacturer Narrative
Event description: as reported, prior to patient contact, when a 'guardia access embryo transfer catheter' was removed from the packaging, it was noted that there were plastic particles on the tip of the catheter.Another unspecified catheter was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use (ifu), and quality control procedures.One transfer catheter was returned in an open inner package without label.The guide catheter was not returned.There was a loose clear color substance on the distal tip of the transfer catheter.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 found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The transfer catheter raw material is provided by a cook supplier.A review of the incoming inspection results for transfer catheter raw material associated with this device had passing results.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook requested that the supplier investigate this occurrence.The supplier reviewed production processes and records relevant to the supplied component and was unable to identify any potential source of the contaminant.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: note: one cell mea tested and passed with 80% or greater blastocyst development within 96 hrs.Usp endotoxin (lal) tested and passed with 20 eu or less per device.How supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile store in a dark, dry, cool place avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred.Review of the work order revealed passing results of the mea and lal testing.Cook has concluded a supplier manufacturing deficiency likely contributed to the reported failure.The supplier has conducted an investigation into the event, but they were unable to identify any potential source of this contaminant from their processing.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 18584440
• Report Number: 1820334-2024-00127
• Device Sequence Number: 8203614
• Product Code: MQF
• UDI-Device Identifier: 00827002347830
• UDI-Public: (01)00827002347830(17)260914(10)15656236
• Combination Product (Y/N): N
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2024

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: 09/14/2026
• Device Catalogue Number: K-JETS-7019
• Device Lot Number: 15656236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 01/26/2024; 05/24/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/19/2024; 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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: Female