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

Model Number G30457

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: non-healthcare professional.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported when using the pivet guide embryo transfer set to absorb the embryo, an unknown liquid was found in the catheter.After rinsing the catheter a few times, the liquid was still on the catheter.The physician used a second device to complete the procedure.No adverse events have been reported as a result of the alleged malfunction.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Additional information: d10 (concomitant medical products).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, the instructions for use, manufacturing instructions, and quality control data.Six devices were returned for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the returned devices noted four of the guide catheters were returned in unopened packages.Two transfer catheters were returned with the syringes attached to the hub.It was noted that an unidentified substance was inside of the transfer catheters.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: caution: sterile if the package is unopened or undamaged.Do not use if package is broken.The assisted reproduction catheter (and any other accessories used during this procedure) should be comprised of embryo compatible materials.Note: one cell mouse embryo tested and passed with 75% or grater blastocyst rate.Usp endotoxin (lal) tested and passed with 20 eu's or less per device.Testing is conducted on a lot-to-lot (batch) basis.Similar events have been observed, where a customer has observed an unknown substance or oily substance inside the transfer catheters.There is an ongoing investigation looking into this matter.This investigation has determined that the contamination is most likely due to nitrate and nitrite salt residues, which dried on to the transfer catheter cannula during the component cleaning process.The cannula components are supplied by a third party supplier.When the finished goods are exposed to the ethylene oxide (eto) sterilization process, a chemical reaction occurs between eto and the nitrate and nitrite salts.This chemical reaction was the cause for the color change of the dried substance.The way the product is packaged, detection of contamination of the transfer catheter is not possible as the transfer catheter with its¿ product protector is placed under the guide catheter in the final outer package.As the contamination would only be visible after the sterilization process and the product is removed from the package, this failure would not have been found during the manufacturing process.The third-party supplier has implemented testing each order of cannula prior to release to mitigate the occurrence of the contamination of the cannula with nitrates and nitrites.Appropriate measures are being conducted (have been taken) to address this failure mode.The complaint is confirmed based on the customer's testimony and the evaluation of the returned complaint devices.The cause of this event occurrence is contributed to a supplier manufacturing and quality error.The risk analysis for this failure mode was reviewed and no further risk mitigation is required; however due to the specific form of contamination, further investigation into this failure is ongoing.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.

• Brand Name: PIVET GUIDE EMBRYO TRANSFER SET
• Type of Device: MQF CATHETER, ASSISTED REPRODUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8377746
• MDR Text Key: 138423870
• Report Number: 1820334-2019-00529
• Device Sequence Number: 1
• Product Code: MQF
• UDI-Device Identifier: 00827002304574
• UDI-Public: (01)00827002304574(17)210829(10)9084956
• Combination Product (y/n): N
• PMA/PMN Number: K983594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2021
• Device Model Number: G30457
• Device Catalogue Number: K-PETS-5000
• Device Lot Number: 9084956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 50