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 Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 12/05/2008

Event Type  Injury  

Manufacturer Narrative

Date of event is approximated to (b)(6) 2008, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.Implanting surgeon:(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system and a repliform tissue regeneration matrix were implanted during a total vaginal hysterectomy, anterior-posterior colporrhaphy, vagina, with repliform augmentation of anterior repair, vaginal cuff suspension with transobturator tape and hysteroscopic examination procedure performed on (b)(6) 2008 for the treatment of symptomatic pelvic relaxation, third-degree cystocele, first-degree rectocele, first-degree uterine prolapse and stress urinary incontinence.After placement of the obtryx and removal of the sleeves, bleeding was noted in the left periurethral space which was resolved using 2-0 vicryl sutures.As reported by the patient's attorney, the patient experienced an unspecified injury.

• 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: 15971871
• MDR Text Key: 305410999
• Report Number: 3005099803-2022-05733
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718970
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2022

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
• Device Operator: Health Professional
• Device Model Number: M0068504000
• Device Catalogue Number: 850-400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female