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

Model Number	M0068505000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Prolapse (2475); Dysuria (2684); Constipation (3274); Unspecified Tissue Injury (4559)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of april 14, 2021, was chosen as the best estimate based on the implant date.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: imdrf patient code e1301 captures the reportable event of rectal and vaginal prolapse.Imdrf patient code e2330 captures the reportable event of back pain and chronic pelvic pain.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e2015 captures the reportable event of urethral atrophy.Imdrf patient code e1007 captures the reportable event of chronic constipation.Imdrf patient code e1301 captures the reportable event of dysuria.Imdrf impact code f2303 captures the reportable event of additional medical treatment and procedures.Imdrf impact code f1903 captures the reportable event of removal of the pelvic mesh product.
Event or Problem Description
It was reported to boston scientific corporation that an obtryx system - halo device was implanted during a procedure performed on (b)(6) 2021.As a result of the implantation of the pelvic mesh, the patient suffered the injuries such as rectal and vaginal prolapse, back pain, abdominal pain, urethral atrophy, chronic pelvic pain, chronic constipation, and dysuria.Additionally, the patient underwent additional medical treatment and procedures, including repair and pelvic mesh removal.
Additional Manufacturer Narrative
Blocks a2, b5 and b7 have been updated based on the additional information provided on january 3, 2024.Block h11: correction to block d7a.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as the best estimate based on the implant date.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: imdrf patient code e1301 captures the reportable event of rectal and vaginal prolapse.Imdrf patient code e2330 captures the reportable event of back pain and chronic pelvic pain.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e2015 captures the reportable event of urethral atrophy.Imdrf patient code e1007 captures the reportable event of chronic constipation.Imdrf patient code e1301 captures the reportable event of dysuria.Imdrf impact code f2303 captures the reportable event of additional medical treatment and procedures.Imdrf impact code f1903 captures the reportable event of removal of the pelvic mesh product.
Event or Problem Description
It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a robotic-assisted laparoscopic sacrocolpopexy, cystoscopy, obtryx transobturator urethral sling, and posterior repair procedure performed on (b)(6) 2021.As a result of the implantation of the pelvic mesh, the patient suffered the injuries such as rectal and vaginal prolapse, back pain, abdominal pain, urethral atrophy, chronic pelvic pain, chronic constipation, and dysuria.Additionally, the patient underwent additional medical treatment and procedures, including repair and pelvic mesh removal.

• Brand Name: OBTRYX SYSTEM - HALO
• Common Device Name: 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 ; 5086834015
• MDR Report Key: 18008624
• Report Number: 3005099803-2023-05631
• Device Sequence Number: 17961092
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0026376986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female