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

Model Number ESS-G02-160

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during a procedure on the esophagus performed on (b)(6) 2024.During the procedure, the needle body was closed through tissue and connected to the anchor that was attached to the anchor exchange catheter.The anchor exchange catheter broke or "popped" and the blue release button broke off from the end of the catheter.Once that button broke, the anchor exchange catheter was essentially stuck on the anchor which was stuck on the needle body.It was "fused" with patient tissue in between.The device was removed from patient tissue using an additional device.The procedure was not completed as it was aborted.There were no patient complications reported because of this event.

Manufacturer Narrative

Block h6: impact code f1001 captures the reportable event of absence of treatment.

Manufacturer Narrative

Correction: block h6: imdrf code: a150208 captures the reportable event of stuck.Imdrf code: f1001 captures the reportable event of absence of treatment.

Event Description

It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during a procedure on the esophagus performed on (b)(6) 2024.During the procedure, the needle body was closed through tissue and connected to the anchor that was attached to the anchor exchange catheter.The anchor exchange catheter broke or "popped" and the blue release button broke off from the end of the catheter.Once that button broke, the anchor exchange catheter was essentially stuck on the anchor which was stuck on the needle body.It was "fused" with patient tissue in between.The device was removed from patient tissue using an additional device.The procedure was not completed as it was aborted.There were no patient complications reported because of this event.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURE 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: 19087208
• MDR Text Key: 340355890
• Report Number: 3005099803-2024-01663
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: 20811955020661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181141
• 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,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Lot Number: 2022101425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2022
• 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