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

Model Number M0068505110

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

Patient Problems Abdominal Pain (1685); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Discomfort (2330); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 07/31/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx ll system - halo device was implanted into the patient during a procedure performed on (b)(6), 2018.As reported by the patient's attorney, the patient experienced pelvic and abdominal pain and discomfort that is chronic in nature, scarring, inflammation, dyspareunia, urinary dysfunction, and mental and emotional pain and anguish as a result of the implantation.She also claimed to have suffered past and future pain and suffering; past and future mental and emotional anguish; past and future physical injury and deformity; past and future physical disability including sexual dysfunction; past and future medical care and treatment.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6), 2018, the implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e1309 - urinary retention, e2330 - pain, e1002 - abdominal pain, e2311 - discomfort, e2308 - deformity, e1715 - scarring, e1405 - dyspareunia, e2401 - physical injury, e2326 - inflammation, e0206 - mental and emotional anguish.Imdrf impact code f1202 captures the reportable event of disability.

• Brand Name: OBTRYX II SYSTEM - HALO
• 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: 17862542
• MDR Text Key: 324821789
• Report Number: 3005099803-2023-05181
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2023
• 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
• Patient Sex: Female