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

Catalog Number	K-J-SPPE-681210-ET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that during an embryo transfer, the soft-pass echotip embryo transfer catheter set was used.During extraction of an empty catheter from the patient, that was inserted for a first trial, the tip of the transfer catheter was struck and as a result the metal part was detached and remained in the patient's uterus.During the extraction, the catheter extended beyond its normal length.The doctor decided to wait for the patient's menstruation to wash it out.Now it's out of the patient's body.The patient will need to come in for another embryo transfer procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: visual inspection of the returned products was conducted.A review of complaint history, the device history record, manufacturing instructions, quality control data, and specifications has also been performed.Two devices (one used and one opened) were returned for investigation.A visual examination noted the used device was returned without the echo tip band.The outside diameter (o.D.) of the transfer catheter distal tip measured outside of specification.The unused device was returned with the echo tip band.With minimal pressure, the echo tip band came off.The o.D.Of the catheter tip measured outside of specification.And additional one hundred fifteen unopened devices were returned for investigation.15 of the unopened devices were opened for investigation.The echo bands appear secure.The o.D.Of the catheter tips measure within specifications.The additional 100 devices were later opened for investigation on august 14, 2018.The security of the echo band and the tip o.D.Was checked.The echo bands were all secure on the transfer catheters and the o.D.Of the catheter tips measured within specifications.Review of the device history records noted there were 29 damaged marker bands identified during production.These non-conforming items were scrapped.A review of complaint history revealed this is the only complaint associated with complaint lot number 8470624.Based on the information available the cause of this issue with the two opened devices could not be determined.There were no problems identified with the other 115 devices returned by the customer.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.
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: 7526428
• Report Number: 1820334-2018-01506
• Device Sequence Number: 13766632
• Product Code: MQF
• UDI-Device Identifier: 00827002189546
• UDI-Public: (01)00827002189546(17)201226(10)8470624
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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 Catalogue Number: K-J-SPPE-681210-ET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 10/31/2018
• Patient Sequence Number: 1
• Patient Age: 35 YR