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

Catalog Number	K-J-SPPE-681700-ET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/21/2017
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 at the time of making an embryo transfer, the echotip from the soft-pass echotip embryo transfer catheter set had detached and was left inside the patient.The echotip from the catheter was not retrieved.The doctor stated that the catheter had been reused by his assistant.Per the instructions for use (ifu) the device is intended for one-time use.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
The piece is still inside the patient.The doctor will evaluate at the next visit of the patient.He is trying to preserve the pregnancy.
Additional Manufacturer Narrative
Method codes: 4114, device not returned.Investigation evaluation.The complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, quality control data and specifications.The device history records were reviewed for lot number 7679019 and noted there are no conformances that may have caused or contributed to this incident.A review of complaint history records revealed there have been no other complaints associated with the complaint device lot number 7679019.Per the instructions for use (ifu), this device is intended for one-time use.The label also illustrates ¿one time use only.¿ there is no information surrounding any difficulties encountered during the procedure.There is no information about other devices used in the procedure and if these other devices (e.G., wire guides, guiding catheters, obturator) met their manufacturer¿s quality specifications.It is not known how the device was handled between uses.The ability of the device to withstand multiple procedures has not been studied.Based on the fact, that the device appears to have functioned properly during the first procedure, and based on its ability to be used again, the manufacturing of the device is not suspected to have been faulty.The most likely contributing factor to this failure is the off-label - reuse of the device.Per the quality engineering risk assessment, based on the rare nature of this failure mode, no further action will be taken at this time.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
Despite our attempts to obtain additional information regarding the patient status/outcome, no new information has been forthcoming since the last report was submitted on 05jun2018.

• 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: 7451936
• Report Number: 1820334-2018-01190
• Device Sequence Number: 1233189
• Product Code: MQF
• UDI-Device Identifier: 00827002186583
• UDI-Public: (01)00827002186583(17)200215(10)7679019
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 08/31/2018

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-681700-ET
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 04/24/2018; 08/23/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 06/05/2018; 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 54