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 Abdominal Pain (1685); Fatigue (1849); Pain (1994); Burning Sensation (2146); Discomfort (2330); Numbness (2415); Sleep Dysfunction (2517); Constipation (3274); Movement Disorder (4412); Paresthesia (4421)

Event Date 02/02/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was implanted into the patient during a transobturator tape (tot) procedure performed on (b)(6) 2021.After the procedure, the patient complained of right thigh pain, groin pain, sciatic leg pain, hip pain, buttock pain, and lower back pain.She has difficulty sitting or standing for too long, walking, getting in and out of the car, and climbing the stairs.She has a tingling sensation in her leg and a burning sensation in the buttock, thigh, and lower back.She limps whenever she gets out of the car.She has a blocked hip and pelvis sensation.She has pain and discomfort in her lower right belly and has right groin sensitivity.The patient can no longer feel her straight leg and foot due to feeling numb.She has difficulty sleeping because the position on one side is complicated; there is stab-like pain in her hip and buttocks.She has fatigue and frequent constipation.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2021, implant date, as no event date was reported.Block h6: imdrf patient code e2303 captures the reportable event of pain.Imdrf patient code f1202 captures the reportable event of difficulty sitting or standing for too long, walking, getting in and out of the car, and climbing the stairs.

• 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: 18838886
• MDR Text Key: 336957924
• Report Number: 2124215-2024-12252
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

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: 10/01/2023
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0026111361
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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; Required Intervention