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

Model Number	M0068504110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an obtryx transobturator midurethral sling system device was implanted into the patient during cystoscopy with fulguration of hemangioma + transobturator sling placement procedure performed on (b)(6) 2019 for the treatment of stress incontinence, bladder hemangioma and microscopic hematuria.After the implant, it was reported that the patient had mesh erosion.On (b)(6) 2020, the patient underwent removal surgery of exposed mesh.After the removal, palpation was carefully done and there was no evidence of any residual or exposed sling and no immediate postoperative complications.
Additional Manufacturer Narrative
Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date the exposed mesh was removed.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: OBTRYX LL 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13933162
• Report Number: 3005099803-2022-01591
• Device Sequence Number: 19997215
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: 08714729839255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040787
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

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: 02/06/2022
• Device Model Number: M0068504110
• Device Catalogue Number: 850-411
• Device Lot Number: 23310993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female