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

Model Number M0068504000

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

Patient Problems Erosion (1750); No Code Available (3191)

Event Date 09/07/2011

Event Type  Injury  

Manufacturer Narrative

Udi #, device manufacture date: the reported lot number (1ml0120502) does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.This event was reported by the patient's legal representation.The implant surgeon is: (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

Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an uphold vaginal support system and obtryx system - curved devices were implanted into the patient during a procedure performed on (b)(6) 2011.As reported by the patient's attorney, after the implantation, the patient experienced mesh exposure and had resection of the exposed mesh and revision of vaginal cuff on (b)(6) 2011.On (b)(6) 2017, the patient underwent revision of mesh and cystoscopy.Subsequently, both devices were removed from the patient on (b)(6) 2017.

• Brand Name: OBTRYX 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: 11191137
• MDR Text Key: 227511019
• Report Number: 3005099803-2021-00134
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718963
• UDI-Public: 08714729718963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• 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: 01/18/2021

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 Model Number: M0068504000
• Device Catalogue Number: 850-400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention