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

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Suture Abrasion (2497)
Date of Event	07/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a patient had a gastropexy with insertion of a percutaneous gastrostomy tube on (b)(6) 2016 and developed pressure sores around the entuit suture anchor insertion site.Reportedly the patient was brought back to radiology for suture removal.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), trends and quality control of the device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: while maintaining slight tension on the trailing suture, introduce the distal spring coil of the wire guide into the needle and use it to push the anchor out of the needle into the stomach cavity.Maintain slight tension on the suture during anchor introduction.Remove the introducer needle over the wire guide.With the wire guide still in position, apply traction to the suture to pull the anterior wall of the stomach against the abdominal wall." the ifu also states, "note: the sutures may be left in place for two weeks while tract formation occurs, or they may be cut after gastrostomy catheter placement." the current ifu, includes the additional precautions in the warning section: gastropexy site should be checked daily for early signs of pressure ulcers, including discoloration and tenderness around gastropexy site.Patients with ascites may be at an increased risk of complications, including pressure ulcers.Additional site monitoring should be implemented for these patients.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.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, measures have been taken to address skin irritation caused by this device.
Event or Problem Description
It was reported that a patient had a gastropexy with insertion of a percutaneous gastrostomy tube on (b)(6) 2016 and developed pressure sores around the entuit suture anchor insertion site.Reportedly the patient was brought back to radiology for suture removal.

• 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: 5904498
• Report Number: 1820334-2016-00850
• Device Sequence Number: 16244323
• Product Code: FGE
• UDI-Device Identifier: 00827002355620
• UDI-Public: (01)00827002355620(17)181129(10)6412394
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: GIAS-SRM-ADJ-2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2016
• Supplement Report FDA Received Date: 11/15/2016
• 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: Other
• Patient Age: 73 YR