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 Pain (1994); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Insufficient Information (4580)

Event Date 02/21/2023

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2023, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e2330 - captures the reportable event of significant pain.E2401 - captures the reportable event of the patient being severely and debilitatingly injured.E2308 - captures the reportable event of disfigurement.E0206 - captures the reportable event of loss of enjoyment of life, loss of care, mental pain and suffering.The following imdrf impact code capture the reportable event of: f12 - captures the reportable event of the had filed a legal claim for the injuries sustained related to the device.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a posterior colporrhaphy, perineorrhaphy, tension-free vaginal tape placement, and cystoscopy procedure performed on (b)(6) 2023, for the treatment of rectocele, stress urinary incontinence and widened vaginal introitus.No complications were noted throughout the procedure, and the patient tolerated the procedure well and was transferred to the recovery room in stable condition.It was alleged the patient has experienced significant pain, embarrassment, disfigurement, and harm resulting from the device's implantation.Additionally, the patient has been severely and debilitatingly injured, and sustained severe and permanent pain, suffering, disability, impairment, loss of enjoyment of life, loss of care, mental pain and suffering and economic damages.The patient may require further surgery and may continue to suffer significant pain and unnecessary medical expenses for medical care, treatment, and therapies long into the future.

• 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: 17825504
• MDR Text Key: 324366118
• Report Number: 3005099803-2023-05146
• 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: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• 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
• Device Lot Number: 0030882400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Female