MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068505000

Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)

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

Event Date 09/15/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was used during an unspecified surgical procedure.During the procedure, "when the physician was adjusting the sling strap, it moved from its ideal position and broke." the reported event is unclear; however, the information suggests the sleeve may have detached during tensioning.Attempts were made to clarify the circumstances surrounding this event as well as the current location of the device, and no further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf device code a1502 captures the reportable event of sleeve detachment.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was used during an unspecified surgical procedure.During the procedure, "when the physician was adjusting the sling strap, it moved from its ideal position and broke." the reported event is unclear; however, the information suggests the sleeve may have detached during tensioning.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf device code a1502 captures the reportable event of sleeve detachment.Block h10: upon receipt at our quality assurance laboratory, this obtryx system underwent a thorough analysis.Visual inspection of the delivery devices did not identify any anomalies.Inspection noted that the mesh was stretched; additionally, centering tab, sleeves, and dilators were not returned.Based on the information available, boston scientific concludes that the reported allegation of sleeve detachment was confirmed.It is most likely procedural conditions, such as user handling technique during placement or advancement of the mesh, resulted in excessive force on the mesh and sleeve, causing the mesh to be stretched and the sleeve to be detached.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.However, it is important to note the ifu provides detailed instructions to ensure the optimal strategy is used when placing the mesh.Including warnings indicating: if excessive force is encountered during advancement/withdrawal, stop, and determine remedial action prior to proceeding.Avoid excessive tension on the mesh during handling.A conclusion code of adverse event related to procedure was assigned to this investigation.

• Brand Name: OBTRYX SYSTEM - HALO
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17876458
• MDR Text Key: 324986494
• Report Number: 3005099803-2023-05348
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718994
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K040787
• 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,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0029997204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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