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

Catalog Number	K-PETS-5000
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).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 was reported, while prepping for an in vitro fertilization (ivf) procedure, prior to using the pivet guide embryo transfer set, the user found, under a microscope, that there were unknown foreign filaments at the inner catheter orifice.Another same type of transfer catheter was used to finish the procedure successfully.No patient involvement.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation included a review of complaint history, the device history record, and quality control data.One device was returned for investigation.A visual examination noted foreign matter inside the catheter.The device history lot record was reviewed and noted two non-conformances associated with the reported failure of foreign matter loose.The appropriate product and quality managers have been alerted.A search of complaint records found this is one of two complaints for the same issue associated with the complaint device lot number 8196053.The cause for this failure event is due to a manufacturing/packaging error.This issue has been brought to the attention of the product manager and quality manager¿s attention.Cook medical will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
It was reported, while prepping for an in vitro fertilization (ivf) procedure, prior to using the pivet guide embryo transfer set, the user found, under a microscope, that there were unknown foreign filaments at the inner catheter orifice.Another same type of transfer catheter was used to finish the procedure successfully.No patient involvement.

• 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
• MDR Report Key: 7657890
• Report Number: 1820334-2018-01842
• Device Sequence Number: 2062859
• Product Code: MQF
• UDI-Device Identifier: 00827002304574
• UDI-Public: (01)00827002304574(17)200927(10)8196053
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K983594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: 09/27/2020
• Device Catalogue Number: K-PETS-5000
• Device Lot Number: 8196053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR