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

Model Number	M0068505110
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a mid-urethral sling placement procedure using an obtryx ii system - halo, when the physician was trimming the mesh of the skin, cutting through the plastic sheath and mesh behind the blue dilators, she lost the grip on the sheath and fell into the patient.The physician then attempted to dissect the vaginal incision to reach up through the sling pathway to grab hold of the plastic sheath, but she could not find it.The patient's incisions were then closed up, and the patient stayed in the hospital for monitoring.
Additional Manufacturer Narrative
Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0501 captures the reportable event of plastic sheath detachment.

• Brand Name: OBTRYX II SYSTEM - HALO
• Common Device Name: 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
• MDR Report Key: 20364087
• Report Number: 2124215-2024-62003
• Device Sequence Number: 6860084
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown