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	Purulent Discharge (1812); Pressure Sore/Ulcer (2326)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: entuit gastrostomy br balloon retention feeding tube- sbrd-16; entuit start initial placement gastrostomy set-ipsg-m.(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
The international customer reported that 10 days following placement of the entuit secure gastrointestinal suture anchor set, the patient presented with pus-containing and necrotic wounds, which were located under the anchors.The product issue necessitated the disinfection and wound care measures.The customer confirmed that when deploying the adjustable anchors, slightly loosening them after placement avoids the problem of necrotizing irritation.The device is reportedly unavailable for return and evaluation.
Event or Problem Description
The international customer reported that 10 days following placement of the entuit secure gastrointestinal suture anchor set, the patient presented with pus-containing and necrotic wounds, which were located under the anchors.The product issue necessitated the disinfection and wound care measures.The customer confirmed that when deploying the adjustable anchors, slightly loosening them after placement avoids the problem of necrotizing irritation.The device is reportedly unavailable for return and evaluation.Additional information received from representative: the radiologist reported that the patient is reviewed for the entuit only 10 days after the procedure and not reviewed everyday like instructions for use (ifu).
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation - evaluation: a review of the complaint history, device history record, drawings, instructions for use(ifu), manufacturing instructions, and quality control data was completed during this investigation.A complaint device evaluation was not performed since no product or imaging was returned to assist with this investigation.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.It was stated by the customer that when the adjustable suture retention mechanisms are slightly loosened just after laying on the patient, the problem of necrotizing irritation is avoided.Per the provided ifu, ¿gastroplexy site should be checked daily for early signs of pressure ulcers, including discoloration and tenderness around gastropexy site.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 gastropexy bolster should contact the skin but not create any visible skin indentation when at optimal tension.¿ based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.However, measures have been initiated to address this failure mode.Measures have been initiated to address this issue.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
Additional Manufacturer Narrative
A response letter has been sent to the user facilities in order to point out the error in procedure use and inform the facilities of proper protocols according the ifu.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Blank fields on this form indicate the information is unknown, unchanged or unavailable.Blank fields on this form indicate the information is previously submitted, unknown, or unavailable.

• 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: 7219574
• Report Number: 1820334-2018-00043
• Device Sequence Number: 16447370
• Product Code: FGE
• UDI-Device Identifier: 00827002355637
• UDI-Public: (01)00827002355637(17)200824(10)8165201
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 12/21/2017
• Supplement Date Received by Manufacturer: 01/31/2018; 04/10/2018; 04/03/2018
• Initial Report FDA Received Date: 01/25/2018
• Supplement Report FDA Received Date: 03/02/2018; 04/13/2018; 04/17/2018
• 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
• Patient Age: 67 DA