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

Model Number	M0068505000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Urinary Frequency / Polyuria (2275); Prolapse (2475)
Date of Event	04/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an obtryx system - halo device was used during a procedure.The patient experienced pelvic heaviness and needs to urinate frequently.Other pains have also appeared progressively, such as back, pelvic, hip, sternum, shoulder, and foot pain.Additionally, the patient also had anal and vaginal burning.
Additional Manufacturer Narrative
Block h6: patient code e2330 captures the reportable event of pain.Patient code e1705 captures the reportable event of vaginal burning.
Additional Manufacturer Narrative
Correction to blocks h6 (patient codes), and h11.Block h6: patient code e2330 captures the reportable event of pain.Patient code e1705 captures the reportable event of vaginal burning.
Event or Problem Description
It was reported that an obtryx system - halo device was used during a procedure.The patient experienced pelvic heaviness and needs to urinate frequently.Other pains have also appeared progressively, such as back, pelvic, hip, sternum, shoulder, and foot pain.Additionally, the patient also had anal and vaginal burning.

• Brand Name: OBTRYX 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: 20698868
• Report Number: 2124215-2024-70144
• Device Sequence Number: 12379859
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2026
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0032118529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/12/2024
• Date Device Manufactured: 07/31/2023
• 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: Female