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

Model Number	M0068504000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Prolapse (2475); Dyspareunia (4505); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572)
Date of Event	11/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event was approximated to november 8, 2017, implant date, as no event date was reported.Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1304 captures the reportable event of overactive bladder.Imdrf patient code e1405 captures the reportable event of painful intercourse.Imdrf patient code e1720 captures the reportable event of bladder irritation.Imdrf patient code e2006 captures the reportable event of mesh extrusion.Imdrf patient code e0506captures the reportable event of heavy vaginal bleeding.Imdrf impact code f12 captures the reportable event of serious injury.
Event or Problem Description
It was reported that an obtryx system-curved device was implanted during a procedure performed on (b)(6) 2017.Due to the implantation, the patient experienced severe dyspareunia, stress urinary incontinence, overactive bladder, mesh extrusion, bladder irritation, pelvic pain, uterovaginal prolapse, and heavy vaginal bleeding.

• Brand Name: OBTRYX SYSTEM - CURVED
• 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: 19470411
• Report Number: 2124215-2024-32063
• Device Sequence Number: 7423441
• Product Code: OTN
• UDI-Device Identifier: 08714729718963
• UDI-Public: 08714729718963
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: 07/18/2020
• Device Model Number: M0068504000
• Device Catalogue Number: 850-400
• Device Lot Number: 0020905678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/05/2024
• Date Device Manufactured: 07/19/2017
• 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