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	07/27/2017
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 start of necrosis to the skin" more than 10 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 four medwatch reports being submitted as the customer reported four patient event s occurring over a one month time frame.Reference mdr numbers 1820334-2017-02358, 1820334-2017-02359 and 1820334-2017-02360 for all associated reports.
Additional Manufacturer Narrative
A review of the complaint history, device history record, manufacturing instructions, quality control, instructions for use, specifications, and drawings was conducted during the investigation.No issues were found related to the reported complaint.The complaint device was not returned; therefore no physical examination could be performed.The device history record was reviewed and no non-conformances were identified.A thorough review of complaint history search revealed that this is the only recorded complaint associated with this lot number.Per the ifu, ¿sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.¿it was confirmed by a cook sales representative that the packaging was not damaged or opened prior to 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.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.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: 6811680
• Report Number: 1820334-2017-02357
• Device Sequence Number: 992860
• Product Code: FGE
• UDI-Device Identifier: 00827002355637
• UDI-Public: (01)00827002355637(17)200613(10)7985389
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: 08/09/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 11/16/2017
• 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