MAUDE Adverse Event Report: COOK INC SYDNEY IVF MICROVOL EMBRYO TRANSFER CATHETER SET; MQF CATHETER, ASSISTED REPRODUCTION

Model Number	G18740
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It has been reported that prior to an in vitro fertilization (ivf) procedure of an embryo transfer into the uterine cavity of a (b)(6) year old female patient using a sydney ivf microvol embryo transfer catheter set, the healthcare professional noted an impurity in the catheter.Another similar device was used to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.
Event or Problem Description
There is no new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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, drawings, quality control data, and specifications.One device was returned for investigation.The visual examination noted unknown foreign matter in the catheter.Under magnification, prior to flushing the catheter with 2.5 ml of deionized water, the unknown foreign matter was confirmed on the inner lumen.After flushing with 2.5 ml of deionized water, the unknown foreign matter did not move position.Under microscopic magnification the "unknown foreign matter" resembled material imperfections similar to micro-scratches or air pockets.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The complaint device was observed under magnification and confirmed the presence of some unknown anomaly.After flushing the catheter, with de-ionized water, the unknown anomaly was observed under microscopic magnification and the anomaly resembled material imperfections similar to micro scratches, air pockets or micro-cracks in the catheter material.Current quality control documentation calls for the device inspection for foreign matter and device flaws, this complaint will not be considered as manufactured out of specification as the material imperfection is only noticeable under magnification.As a sample of each lot is mouse embryo assay (mea) tested prior to distribution, it is likely that the complaint device would have functioned without issue and not hindered embryo cell growth.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database 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.

• Brand Name: SYDNEY IVF MICROVOL EMBRYO TRANSFER CATHETER SET
• Common Device Name: MQF CATHETER, ASSISTED REPRODUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8842415
• Report Number: 1820334-2019-01871
• Device Sequence Number: 1400725
• Product Code: MQF
• UDI-Device Identifier: 00827002187405
• UDI-Public: (01)00827002187405(17)220102(10)9380559
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K983594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: 01/02/2022
• Device Model Number: G18740
• Device Catalogue Number: K-JETS-7019-SIVF
• Device Lot Number: 9380559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 56