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

Model Number M0068505000

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

Patient Problems Pain (1994); Anxiety (2328); Depression (2361); Prolapse (2475); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)

Event Date 08/17/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a procedure performed on (b)(6) 2021.As reported by the patient's attorney, post-procedure, the patient experienced pelvic pain, vaginal pain, back pain, vaginal spasms, failed sling, cystocele, dyspareunia, and urinary incontinence, furthermore, the patient claims to have suffered the following damages as a result of the implantation of the prior designated pelvic mesh product(s): economic damages such as medical bills, out-of-pocket expenses, and lost wages, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury, and more.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to august 17, 2021, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation: the implanting facility is: (b)(6) medical center (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - captures the reportable events of pelvic pain and vaginal pain.E020201 - captures the reportable event of anxiety.E020202 - captures the reportable event of depression.E0206 - captures the reportable event of suffering and loss of enjoyment of life.E1405 - captures the reportable event of dyspareunia.The following imdrf impact codes capture the reportable events of: f1202 - captures the reportable event of physical impairment, permanent physical injury, and more.

• Brand Name: OBTRYX 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18503711
• MDR Text Key: 332786942
• Report Number: 2124215-2023-75935
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• 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: 01/12/2024

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: 09/14/2023
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0026010851
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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 Sex: Female