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 Code	Unspecified Infection (1930)
Date of Event	07/07/2017
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 on chemotherapy for an unspecified indication underwent an unspecified gastrointestinal procedure using an entuit secure gastrointestinal suture anchor set.The patient reported discomfort to the clinical staff at an unknown time following implantation.The nursing staff released the suture anchors at a time more than 2 weeks post insertion.The customer reported that the site of the suture anchors "became red and festery looking and possibly infected." the general practitioner examined the site and provided antibiotic cream since patient is having chemotherapy.No cultures results of the site were provided.No further information was provided.The device is not available for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation a review of device history record, drawing, quality control, manufacturing instructions, complaint history, and instructions for use (ifu) was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was 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 no other reported complaints for this lot number.The instruction for use states that the site should be checked daily for early signs of pressure ulcers, redness, tenderness, etc.It also states that the anchors should remain in place for 10 to 14 days.There is a tension adjustment for sutures that are too tight.There is no indication that these adjustment procedures were used.Additionally, one precaution notes that this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of gastrointestinal suture anchors should be employed.While the ifu speaks to tension adjustment to relieve pressure, these adjustments are most likely based on the user's experience and judgment for making precise adjustments.There is no definitive evidence that the device malfunctioned.It is feasible that no adjustments were made in the tension of the sutures to relieve patient discomfort and that the anchors were left in place past 14 days.While not definitive, this could likely have contributed to the infection that was noted.Based on the provided information, the root cause is likely user technique.However, based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.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: 6763423
• Report Number: 1820334-2017-02241
• Device Sequence Number: 16516711
• Product Code: FGE
• UDI-Device Identifier: 00827002355637
• UDI-Public: (01)00827002355637(17)191118(10)7456282
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 10/31/2017

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: 07/12/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1