MAUDE Adverse Event Report: COOK INC PIVET GUIDE EMBRYO TRANSFER SET; MQF CATHETER, ASSISTED REPRODUCTION

Model Number	G30457
Medical Device Problem Codes	Complete Blockage (1094); Contamination (1120); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - name and address: postal code: (b)(6).Phone: (b)(6).E3 - occupation: agent.G4 ¿ pma/510(k) #: 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.
Event or Problem Description
It was reported, before aspirating the embryo, the user checked that the outer package of the pivet guide embryo transfer set was intact and there was no obvious damage.However, when the user disassembled the white outer tube of the pivet guide embryo transfer set, and prepared to insert it, the user found that the mouth of the white outer tube was blocked and there was obvious dirt.So, the user replaced it with a new catheter to solve the problem and the transfer went smoothly.The in vitro fertilization (ivf) embryo transfer procedure was completed by using another new device.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Corrections: h6 (annex a, annex g): b5: additional information received 08dec2024.Functional tests and visual inspection of the returned complaint device was also conducted.One, used, device was returned for investigation.Based on the device failure analysis, examination of the returned device revealed the guide catheter hub was occluded with excess device material.Based on the evidence, it appears the step that would have detected the guide catheter occlusion was missed during the quality control process.As each device set was individually checked for occlusion, it is unlikely this issue affects the entire lot.Additionally, foreign matter was noted, however, this was able to be pushed out of the catheter.Upon examination of the foreign matter, it was found to be of reddish color, consistent with biomatter.Additional information was requested to confirm if the device did come into contact with the patient and it was confirmed that the device did come into contact with the patient.Based on this information, the matter has been determined to be dried biomatter, which is not considered 'foreign matter', therefore, this complaint is no longer considered reportable.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.
Event or Problem Description
Additional information received 08dec2024: the catheter did come into contact with the patient.

• Brand Name: PIVET GUIDE EMBRYO TRANSFER SET
• 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: 20181824
• Report Number: 1820334-2024-01202
• Device Sequence Number: 15519145
• Product Code: MQF
• UDI-Device Identifier: 00827002304574
• UDI-Public: (01)00827002304574(17)261205(10)15787587
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/18/2024

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 Model Number: G30457
• Device Catalogue Number: K-PETS-5000
• Device Lot Number: 15787587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 12/08/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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 Age: 32 YR
• Patient Sex: Female
• Patient Weight: 52 KG