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

Model Number	N/A
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Peritonitis (2252); Pneumoperitoneum (4819)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 50-year-old male patient developed peritonitis following placement of a chait percutaneous cecostomy catheter.A percutaneous endoscopic cecostomy was performed on (b)(6) 2023.The catheter was placed in the cecum with three anchors stretched to the skin.No immediate complications occurred during the procedure or the following day.After the first irrigation 48 hours later on (b)(6) 2023, the patient experienced a sudden onset of abdominal pain and contracture.An immediate ct scan was done and showed pneumoperitoneum and peritonitis.During the midline laparotomy that followed, it was found that right and superior anchors placed during the initial procedure had loosened, causing the cecum to pull away from the parietal peritoneum.Diffuse purulent peritonitis was confirmed.The cecal orifice was on its anti-mesocolic face, punctiform (3mm).The cecum was well vascularized.The chait pigtail catheter was found to be in place in the cecum.Bacterial sampling was completed.The chait catheter was then removed from the patient and the closure of the 3mm orifice left behind was completed with 4/0 sutures with epiploplasty.A peritoneal lavage was then performed.The patient then underwent a malone appendicostomy without intestinal resection.A drain was placed in the douglas anatomical region and expressed itself in the left iliac fossa.The right pararectal neo-appendicostomy was intubated by a foley catheter.Aponeurotic closure was completed with sutures.Cutaneous closure was done with 3/0 sutures and the former cecostomy orifice was washed.No other harm to the patient has currently been reported.Cook is working to obtain additional information regarding the identity (rpn and lot) of the anchors used during the initial procedure; however, this information has not been made available at the time of this report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional common name: exd irrigator, ostomy.Additional product code: exd.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.
Additional Manufacturer Narrative
Correction: h6 - annex a.Investigation / evaluation: it was reported that on (b)(6) 2023, an entuit secure gastrointestinal suture anchor set (rpn: gias-srm-adj-3; lot#: unknown) malfunctioned.The device was placed in the patient on (b)(6) 2023, during an endoscopic cecostomy catheter (rpn: tdcs-100-m) placement procedure for colonic irrigation.The three anchors were placed in the cecum and secured at skin level.There were no complications on the day of the procedure nor the following day.The first irrigation was performed on (b)(6) 2023.At this time the patient experienced sudden onset of abdominal pain with contracture.A ct (computed tomography) scan was performed immediately which showed pneumoperitoneum and peritonitis.The ct also showed that the cecum was not attached to the abdominal wall (parietal peritoneum) and that two of the suture anchor threads were loose.As a result, the patient required an additional surgical procedure.An open laparotomy was performed for abdominal exploration, bacterial sampling, and abdominal washing (lavage).A 15 french drain was placed to drain the peritoneum (make and model unknown).The previous cecostomy opening was closed, and a new appendicostomy (malone procedure) was created.No other adverse events were reported due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used chait cecostomy catheter and three used suture anchors were returned to cook for evaluation.A visual examination was conducted on the returned product.No damage was noted on the returned device.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint device.Cook reviewed the sales history for this customer and was able to narrow down the lot number to 14728867 which is specific to the customer entity within a 3-year time period.A review of the dhrs for the reported complaint device lot: 14728867 and the related subassembly lots revealed no related non-conformances.No other complaints were reported from the affected lot.Cook also reviewed product labeling.Instructions for use (ifu) document [entuit secure adjustable gastrointestinal suture anchor set] is packaged with this device.The intended use section of the product ifu specifies the device is to be utilized for gastropexy.The following information is provided in the product ifu in relation to the reported failure mode: ¿intended use: the entuit secure adjustable gastrointestinal suture anchor set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.¿ the information provided upon review of the dmr, ifu, dhr, and returned device suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded off label use of the entuit suture anchors used to secure the cecum to the abdominal wall may have contributed to this incident.Cook only indicates use of these anchors in the stomach.Although the radiologic techniques for placing tubes within the stomach or cecum are similar, the ability of the tissue to retain suture anchors and the surety that the intestinal serosa can be directly opposed against the abdominal wall using these devices and techniques, is quite different.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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.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.
Event or Problem Description
It was confirmed by the area representative on 05jun2023 that the suture anchors used in the procedure were a cook device (rpn: gias-srm-adj-3).

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17005880
• Report Number: 1820334-2023-00661
• Device Sequence Number: 6776070
• Product Code: FGE
• UDI-Device Identifier: 00827002363922
• UDI-Public: (01)00827002363922(17)250418(10)14597397
• Combination Product (Y/N): N
• PMA/510(K) Number: K152524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2025
• Device Model Number: N/A
• Device Catalogue Number: GIAS-SRM-ADJ-3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 06/05/2023; 07/17/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/07/2023; 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3 ANCHORS (RPN AND LOT UNKNOWN).; COOK THSF-35-80-AES, LOT: 14753789.; RPN: TDCS-100-M, LOT: 14597397.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male