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 Material Integrity Problem (2978)

Patient Problems Erosion (1750); Urinary Incontinence (4572)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

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 date of the revision surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: imdrf patient code e2006 captures the reportable event of erosion of mesh into the ureterovesical junction.Imdrf impact code f1905 captures the reportable event of removal of trans obturator tape sling.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was used during a trans obturator tape (tot) and cystoscopy procedure performed on (b)(6) 2021, for the treatment of stress urinary incontinence.On (b)(6) 2021, a 49-year-old female patient underwent a trans obturator tape (tot) and cystoscopy procedure to treat her stress urinary incontinence.A small incision was made below the urethra, and this was undermined to the inferior ramus of the pubic bone on both sides.Punctures were made over the medial aspect of the obturator foramen bilaterally.The procedure was then completed with no complications and the patient was reported to be in stable condition.On (b)(6) 2021, aside from the previous stress urinary incontinence, the patient was diagnosed with failed trans obturator tape sling.She then underwent a urethral suspension sling cysto, urethrolysis, removal of the trans obturator sling and repair of the erosion at the ureterovesical junction.During the procedure, there was an erosion channel at the urethrovesical junction that did not break the mucosal surface.This was oversewn with 3-0 chromic suture in the running fashion.A new sling was placed without difficulty.

• 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: 17651097
• MDR Text Key: 322291226
• Report Number: 3005099803-2023-04609
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0023830243
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female