MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH 2-0 POLYPROPYLENE SUTURE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number PLY-G02-020-APL

Device Problem Break (1069)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf patient code a0401: captures the reportable event of break.

Event Description

It was reported to boston scientific corporation that a overstitch 2-0 polypropylene suture was used during a endoscopic sleeve gastroplasty procedure performed on (b)(6) 2024.During the procedure the overstitch suture broke.The procedure was completed with another overstitch suture.There were no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH 2-0 POLYPROPYLENE SUTURE
• 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): ASSUT EUROPE SPA; via giuseppe gregoraci 12; rome 00137 ; IT 00137
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18999885
• MDR Text Key: 339034808
• Report Number: 3005099803-2024-01356
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: 10811955020732
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K191439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLY-G02-020-APL
• Device Lot Number: 23SE6742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2023
• 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