MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number ESS-G02-NXT

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an overstitch ess nxt was used on a tore procedure performed on (b)(6) 2024.During the procedure, the physician experienced increased resistance and limited mobility with the overstitch nxt going through the overtube.The physician attempted to access all the areas he normally would with the device prior to taking suture bites but once he attempted to take suture bites the anchor exchange became stuck and he was unable to pass the anchor exchange out the distal end of the device.The anchor exchange was resolved after making multiple attempts to remove the suture and suture and the device were removed.The suture was cut externally.The device was successfully completed using an overstitch gen 2.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf code a1702 is being used to capture the reportable event of device-device.Incompatibility specifically between an overtube and an overstitch device.

• Brand Name: OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): VIANT MEDICAL INC; 620 watson st sw; grand rapids MI 49504
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18923437
• MDR Text Key: 337896153
• Report Number: 3005099803-2024-01045
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: 10811955020893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-NXT
• Device Lot Number: 2024010807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2024
• 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