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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Calcium Deposits/Calcification (1758); Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Urinary Tract Infection (2120)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: patient code e2006 captures the reportable event of bladder erosion.Patient code e0506 captures the reportable event of bleeding at the end of the procedure.Patient code e2314 captures the reportable event of fistula.Patient code e2330 captures the reportable event of pain.Patient code e1310 captures the reportable event of urinary tract infection.Patient code e230901 captures the reportable event of calcifications found.Impact code f1901 captures the reportable event of opening the aponeurosis of the rectus sheath to close the bladder.Impact code f23 captures the reportable event of 2 cysto cath and urinary catheter that has been put in place.
Event or Problem Description
It was reported that an obtryx ii system halo device was implanted into the patient during a previous procedure.Sometime after the procedure, there was mesh erosion into the bladder with calcification on the right side.It was noted that the patient underwent a surgery with complications; there was bleeding at the end of the procedure, and they had to open the aponeurosis of the rectus sheath to close the bladder.Three weeks following the intervention, the patient developed a fistula, resulting in two catheters, a cystocath and a urinary catheter, being placed.Since the initial symptoms, the patient continued experiencing pain and urinary tract infections.It was noted that pain management attempts have not been effective.There have not been any reported further actions to manage the symptoms.

• 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: 22299026
• Report Number: 2124215-2025-40194
• Device Sequence Number: 21160048
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: (01)08714729837565(17)220508(10)23766189
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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: 05/08/2022
• Device Model Number: M0068505110
• Device Catalogue Number: M0068505110
• Device Lot Number: 0023766189
• 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: 05/28/2025
• Initial Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 05/09/2019
• 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: Required Intervention
• Patient Sex: Female