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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971)
Date of Event	06/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient developed "wounds with pus and a necrosis to the skin under the anchors" approximately 15 days following placement of entuit secure gastrointestinal suture anchors for an unspecified indication.The customer indicates that the devices are placed "slightly loosened" to attempt to avoid necrotizing irritation.Culture results and sensitivity are not known.The actions taken by the clinical staff were not provided.The device is not available for evaluation.A follow-up report will be provided if any additional information is received.The product insert warns that "gastropexy site should be checked daily for early signs of pressure ulcers, including discoloration and tenderness around the gastropexy site." this is one of three medwatch reports being submitted as the customer reported three patient events occurring over a one month time frame.Reference mdr numbers 1820334-2017-02732, and 1820334-2017-02733 for all associated reports.
Additional Manufacturer Narrative
A review of the complaint history, device history record, drawing, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to the reported failure mode.There were two other reported complaints for this lot number.The devices were not returned to the manufacturer for evaluation; therefore, a root cause could not be determined.During the investigation, we attempted to review product in-house to identify any additional nonconformances.Sample lots (lot# 8150317, 8165523 & 8228913) were removed from the shelf for manufacturer evaluation.No nonconformances were found with the sample lot numbers.It was confirmed by a cook representative that the packaging was not damaged or opened before use.It is unknown whether the patient had any medical history that would contribute to the infection at the site.This device was involved in a validated sterilization cycle before distribution.Suture anchor sets are sealed in a controlled environment prior to final packaging.Per packaging process, if foreign matter is discovered in final packaging, the sealed devices are placed in a new outer pouch and resealed preceding sterilization.It is feasible to suggest the infection was human anatomy or physiology related, package handling or storage related, procedure related, technique related, or manufacturing related.However, based on the current information a cause for the infection could not be determined.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Ifu states: if signs of pressure ulcer development are detected at gastropexy site, use the extra red plunger provided in the set to adjust the tension of the retention bolster.The sutures may be left in place for 10 to 14 days while tract formation is completed, or they may be cut after gastrostomy catheter placement.This releases the anchors into the stomach, allowing their passage via the gastrointestinal system.The site should be checked daily for early signs of pressure ulcers, including discoloration and tenderness around the gastropexy site.Measures have been initiated to correct this issue.Monitoring will continue to be performed for similar complaints.

• 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: 6824917
• Report Number: 1820334-2017-02730
• Device Sequence Number: 717738
• Product Code: FGE
• UDI-Device Identifier: 00827002355637
• UDI-Public: (01)00827002355637(17)200217(10)7685675
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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-3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 12/06/2017
• 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