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

Catalog Number	K-J-SPPE-681710-ET
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that one normal female blastocyst was thawed in preparation for the embryo transfer procedure.Prior to the embryo transfer procedure a trial transfer was performed using the cook soft-pass echotip embryo transfer catheter set.During the trial transfer the metal of the echo-tip soft-pass embryo transfer catheter was noted to be missing and the transabdominal ultrasound showed a small echogenic area within the lower uterine segment consistent with the metal of the echo-tip catheter.The embryo transfer procedure was cancelled and on the following day a hysteroscopic removal of the metal was successfully done.No further information is available at this time regarding the patient or procedure.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection and tensile testing of unused returned product was performed.In addition, a documentation investigation was performed which included a review of complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, and specifications.The complaint device was not returned for investigation.However, twenty (20) unopened devices of the same lot as the complaint device were returned.Three (3) of these unopened devices were tensile tested and each passed the testing.The device history record was reviewed and noted there were no non-conformances related to the reported failure mode.A review of complaint history revealed there has been no other complaint associated with the complaint device lot number (8196052).Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Without visual, dimensional, and/or functional testing of the actual complaint device, we are unable to determine the likely cause for this event.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: SOFT-PASS ECHOTIP 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: 7203571
• Report Number: 1820334-2018-00016
• Device Sequence Number: 11057033
• Product Code: MQF
• UDI-Device Identifier: 00827002189553
• UDI-Public: (01)00827002189553(17)200906(10)8196052
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K983594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: K-J-SPPE-681710-ET
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR