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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
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
The international customer reported that the braiding of the entuit secure gastrointestinal suture anchor came apart at the proximal end of the device when the operator was trying to advance the white toggle down the suture to secure the suture anchor in place.The procedure was successfully completed using two other gastropexy sutures that were contained in the same kit.The customer confirmed that no additional procedures were required and no patient adverse events occurred as a result of the product issue.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
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
The international customer reported that the braiding of the entuit secure gastrointestinal suture anchor came apart at the proximal end of the device when the operator was trying to advance the white toggle down the suture to secure the suture anchor in place.The procedure was successfully completed using two other gastropexy sutures that were contained in the same kit.The customer confirmed that no additional procedures were required and no patient adverse events occurred as a result of the product issue.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.After further review of the record, it was determined that it should be noted that the customer reported that, to complete the procedure successfully, the white toggle of the device was cut at the skin so that the suture could be passed as intended.
Additional Manufacturer Narrative
After further review of the record, it was determined that it should be noted the white toggle was cut at the skin so that the suture could be passed as intended.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, and visual inspection of the device was conducted during the investigation.This malfunction was further determined to not be likely to cause or contribute to a death or serious injury if the malfunction were to recur.One suture retention mechanism was returned with 12.7cm of suture passed through its lumen.A second 22.5cm section of suture was also returned.The proximal end of the suture passing through the mechanism is frayed.There is discoloration on the distal end of both sutures.The devices appear to have been opened and used.Not clear if patient contact was made.Suture retention mechanism does not appear to be damaged.Additionally, a document based investigation evaluation was performed.A review of the device history records for lot 7754848 , (b)(4) and spooled sutures was conducted.For lot 7754848, no related non-conformances were identified.There were no nonconformances noted for the other mentioned dhrs.Also, a complaint history search revealed no other relevant complaints to any of the respective lots.The instructions for use, t_sgsa_rev4, describe the procedure for placing the gastrointestinal suture anchors.No special precautions, warnings, or handling instructions are noted within the ifu regarding the sutures.Based on the information provided, device analysis, and the results of our investigation, a definitive root cause could not be determined.The root cause of this complaint is inconclusive.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.

• 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: 7073109
• Report Number: 1820334-2017-04207
• Device Sequence Number: 1119688
• Product Code: FGE
• UDI-Device Identifier: 00827002355705
• UDI-Public: (01)00827002355705(17)200316(10)7754848
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 05/22/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: GIAS-SRM-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 02/26/2018; 04/23/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 03/26/2018; 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1