MAUDE Adverse Event Report: COOK INC ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Inflammation (1932); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was not provided, but was described as taking place on the "first week of (b)(6) 2019".Initial reporter - occupation: unknown.Pma/510(k) #: k152524.(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 a gastrostomy procedure on (b)(6) 2018, two entuit secure gastrointestinal suture anchor set was deployed during the treatment of the patient.It was further reported that a "few days" after the procedure, one anchor had migrated and was "out of the stomach, in the skin." this was reported to have caused a gastric leak.The other anchor migrated as well and caused a, " inflammation and a cutaneous injury under the white fixation of the device." the facility made a final comment that, "this situation is painful for the patient and he will have a little surgery to remove the anchor in the bud.It is not know when the additional procedure is to take place." no additional adverse events have been reported in connection with this event.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as an imaging review, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.From this information, there is no evidence suggesting that there is nonconforming product in house or in the field.The complainant supplied cook with images of the procedure and devices mentioned.An image review was completed and suggested that having the sutures pulled too tightly and/or not cut within the specified time frame mentioned in the ifu, could have caused the reported migration and formation of a pressure ulcer.Another possible cause noted in the image review is the patients nutritional state being very poor, which is often seen in patients requiring the reported procedure.Based on the information provided, no product returned and the results of the investigation, a definitive root cause could not be determined.Measures have been taken to address this failure mode.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8469988
• Report Number: 1820334-2019-00723
• Device Sequence Number: 11251598
• Product Code: FGE
• UDI-Device Identifier: 00827002355637
• UDI-Public: (01)00827002355637(17)210503(10)8858685
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2021
• Device Model Number: N/A
• Device Catalogue Number: GIAS-SRM-ADJ-3
• Device Lot Number: 8858685
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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