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

Model Number	M0068504110
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Urinary Retention (2119); Urinary Tract Infection (2120); Stenosis (2263); Dyspareunia (4505)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2022, was chosen as a 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 e1309 captures the reportable event of chronic cystitis cystica.Imdrf patient code e1310 captures the reportable event of string of recurrent infections.Imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e2337 captures the reportable event of narrow and high proximal urethra.Imdrf impact code f1903 captures the reportable event of sling removal.
Event or Problem Description
It was reported to boston scientific corporation that an obtryx ii system - curved device was used during a trans obturator tape suspension and repair of midline defect on the anterior vaginal wall procedure performed on (b)(6) 2021, for the treatment of recurrent stress urinary incontinence and midline cystocele.Due to recurrent stress urinary incontinence and a midline cystocele, the patient had trans obturator tape suspension and repair of a midline defect on the anterior vaginal wall on (b)(6) 2021.The previously placed trans obturator tape had moved proximally and was no longer beneath the mid-segment of the urethra.On (b)(6) 2022, the patient was diagnosed with a string of recurrent infections not responding to antibiotic treatment and found obstructed by a proximal sling after prior sling placement and revision.She was also found to have chronic cystitis cystica and dyspareunia.The patient then underwent cystoscopy, sub urethral sling release, and fulguration of stage 2 chronic cystitis.Cystoscopy revealed a very narrow proximal urethra from the sling placed in the location.Additionally, a chronic cystitis cystica over the trigone and bladder base was found.The sling was divided at the 4 o'clock position and peeled gently from the sub urethral level from left to right.After the procedure, the patient was awakened and taken to the recovery room in good condition and with no complications.

• Brand Name: OBTRYX II SYSTEM - CURVED
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17654139
• Report Number: 3005099803-2023-04610
• Device Sequence Number: 12605248
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: 08714729839255
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• 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
• Report Date (Section B): 08/30/2023

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: 02/27/2023
• Device Model Number: M0068504110
• Device Catalogue Number: 850-411
• Device Lot Number: 0025282361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female