MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM; SUTURING SYSTEM

Model Number CNH-C01-213-L

Device Problem Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

Healthcare professional reported during loading of the suture and when the gold tab was pulled to thread the suture, the cinch also moved into the catheter.Device not administered to the patient.The case continued with a new cinch.Patient was later admitted to icu due to a non-disclosed reason however unrelated to the device.

Manufacturer Narrative

Combined medwatch submitted to the fda on 03nov2023.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of suture cinch deployment difficulty and suture broke during procedure as follows: note: it is the collar that sets the final position of the cinch, not the plug.Caution: the safety spacer must only be removed immediately prior to deploying cinch.Troubleshooting: cinch does not cut the suture when fired: use a suitable accessory through the secondary working channel to cut the suture and remove the cinch.Use standard endoscopic techniques to remove the cut suture.Warning: do not introduce the device with the needle body in its open position.Warning: ensure appropriate suture slack has been created for desired suture path and pattern.Advance anchor exchange and/or manipulate endoscope to create suture slack.Anchor exchange will not install anchor onto the needle body: i.Ensure there is sufficient suture slack, and the suture outside endoscope is not entangled.Ii.Ensure anchor exchange is properly positioned in alignment tube of needle driver.Warnings: only physicians possessing sufficient skill and experience in similar, or the same techniques should perform endoscopic procedures.Note: ensure suture is not tangled after removal from the cartridge.Caution: do not use when valve covers are closed as suture drag will be increased.Caution: if resistance is encountered when advancing the anchor exchange through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly.Ensure that there is sufficient space for the needle to open.Additional information: a device history record (dhr) review was performed as the lot number was provided and the device was not returned.The subject product met all specifications and requirements in effect at the time of manufacture.There are no other complaints against this lot number, af04990, and allegation.Device evaluation summary: the device was not returned as it was discarded.Assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.The user effects of suture cinch deployment difficulty and suture broke during procedure are known and labeled possible adverse event.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; bldg b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 18068179
• MDR Text Key: 327320724
• Report Number: 3006722112-2023-00217
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020756
• UDI-Public: (01)10811955020756(17)20250406(11)20220406(10)AF04990
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CNH-C01-213-L
• Device Catalogue Number: CNH-C01-213-L
• Device Lot Number: AF04990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 34 YR
• Patient Sex: Male