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 Codes	Bent (1059); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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, during a oocyte transfer procedure as the soft-pass echotip embryo transfer catheter set was attempting to enter the cervix, the catheter bent.As reported, the echo tip catheter went around in the cervix twice, and when the speculum was removed, they noticed the echo tip in the vagina, the echo tip was removed from the vagina and then they noticed the tip was missing on the catheter.As reported, they waited for a full bladder, then they used a gynetics tulip embryo transfer device without complications.The device was destroyed and will not be returned.Patient outcome post-procedure, not pregnant.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
Additional information: investigation ¿ evaluation.Visual inspection, dimensional verification and testing of the returned products was conducted.A review of complaint history, the device history record, drawings, quality control data, and specifications has also been performed.Initially the used complaint device was not to be returned to cook medical; as a precaution, due to an active blood borne pathogen the customer intended to dispose of it.However, the customer did return the used complaint device.Review of the photographic evidence returned by the customer shows that the metal band has separated from the catheter.Physical evaluation of this device found the device to measure smaller than specification.Twenty-three unopened devices were also returned for investigation.The packages were opened to conduct a physical investigation.The security of the echo bands was checked and it was noted that with a slight tug, all 23 echo bands slide off the transfer catheter.A visual examination noted the catheter tips have a more bullet shape than the bubble shape normally observed.The echo tip indentations are visible on the catheters.Review of the device history records noted there were no non-conformances that would cause or contribute to the reported failure mode.A review of complaint history revealed this is the only complaint associated with complaint lot number 8206744x.A potential contributing factor that could lead to similar failure events are extensive manipulation of the tip of the transfer catheter and excessive force applied to the metal band of the transfer catheter.The cause for this specific failure mode was determined to be a manufacturing issue.Measures have been initiated to address this issue.Cook medical has notified the appropriate personnel and 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.
Event or Problem Description
There has been no new information received since the last report was submitted.

• 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: 7663678
• Report Number: 1820334-2018-01968
• Device Sequence Number: 13833957
• Product Code: MQF
• UDI-Device Identifier: 00827002189553
• UDI-Public: (01)00827002189553(17)200911(10)8206744X
• Combination Product (Y/N): N
• PMA/510(K) Number: K983594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 09/11/2020
• Device Catalogue Number: K-J-SPPE-681710-ET
• Device Lot Number: 8206744X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 72