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

Model Number M0068504110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient's legal representation.(b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that the patient was diagnosed with stress urinary incontinence.On (b)(6) 2018, she was implanted with an obtryx ii system - curved device during a placement of transobturator sling & cystoscopy procedure performed on (b)(6) 2018 for the treatment of stress urinary incontinence.On (b)(6) 2018, the patient presented to the emergency room with hematuria and passage of clots from her vagina.Pelvic exam revealed a clot in the vagina that drained through the vaginal incision and had caused the separation of the incision, exposing the mesh.She underwent vaginal washout and closure procedure of vaginal laceration.There was no active bleeding noted during the procedure.Subsequently, the patient reportedly had multiple visits to the er (emergency room) for vaginal pain and was complaining of feeling the mesh.A pelvic exam was done with the er (emergency room) and doctors did not reveal any mesh extrusion.She underwent one pelvic exam by her implanting surgeon and it also revealed normal.However, her pain got worse and she wanted the sling out because she was feeling it.After reviewing all the risks associated with the procedure, the patient agreed and decided to proceed with mesh excision surgery.On (b)(6) 2018, the patient underwent excision of vaginal sling and cystoscopy procedure due to extrusion of the vaginal sling.The mesh was completely removed.After the surgery, there was no mesh material left in the vagina on inspection or on palpation.

• Brand Name: OBTRYX II SYSTEM - CURVED
• Type of Device: 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: 11408972
• MDR Text Key: 234617118
• Report Number: 3005099803-2021-00830
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: 08714729839255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: M0068504110
• Device Catalogue Number: 850-411
• Device Lot Number: 0020795276
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR