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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
During the placing of a gastrostomy tube, the doctor had to place anchors in order to attach the stomach wall to the abdominal wall.After the anchor insertion, the radiologist pulled the suture for approach to the stomach from the abdominal wall, but the suture broke.There were no consequences for the patient because the anchors followed the digestive path once released.There was a significant loss of time for the operator and the operator had to use another anchor set to continue the procedure.
Additional Manufacturer Narrative
Investigation/evaluation: no images or devices were returned.However, during the course of the investigation, a review of the complaint history, device history record, instructions for use (ifu), quality control, and drawings was conducted.This complaint is the only complaint reported against lot 6174983.There is no evidence to suggest that the device was not manufactured to specification.Without return of the complaint device we are unable to draw a conclusion as to the root cause of this event.The device is shipped with ifu which states the proper warnings, precautions and instructions for use.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.Per the conclusion of a quality engineering risk assessment, no further action is required.
Event or Problem Description
During the placing of a gastrostomy tube, the doctor had to place anchors in order to attach the stomach wall to the abdominal wall.After the anchor insertion, the radiologist pulled the suture for approach to the stomach from the abdominal wall, but the suture broke.There were no consequences for the patient because the anchors followed the digestive path once released.There was a significant loss of time for the operator and the operator had to use another anchor set to continue the procedure.

• 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: 5581468
• Report Number: 1820334-2016-00168
• Device Sequence Number: 13552608
• Product Code: FGE
• UDI-Device Identifier: 00827002355699
• UDI-Public: (01)00827002355699(17)180902(10)6174983
• 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
• Report Date (Section B): 03/24/2016

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-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2016
• Device Age: 8 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2016
• Supplement Report FDA Received Date: 06/27/2016
• 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