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

Model Number M0068502110

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

Patient Problems Pain (1994); Perforation (2001); Urinary Retention (2119); Urinary Frequency (2275); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Block b3, d6a: approximated based on the reported implant date, (b)(6) 2016.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g3: other: tga device incident report reference no.(b)(4); submitted to tga (therapeutic goods administration) by the patient.Block h6: patient code e1309 captures the reportable event of unable to empty bladder.Patient code e2114 captures the reportable event of perforation on the left side of the bladder.Impact code f1901 captures the reportable event of treatment for perforation.

Event Description

It was reported to boston scientific corporation that an advantage fit device was implanted during a procedure performed in (b)(6) 2016.It was reported that during the procedure, the left side of the bladder was perforated and was then treated during the procedure.After device implantation, over the last 4-5 years, the patient experienced pain during intercourse, sneezing or coughing, groin pain, back pain, thigh pain, and pain where the device is situated.Additionally, the patient reported urinary incontinence and had to go to the toilet many times but always felt that her bladder was not empty and was only able to void a little.

• Brand Name: ADVANTAGE FIT SYSTEM
• 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 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17160185
• MDR Text Key: 317460026
• Report Number: 3005099803-2023-03129
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2023

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
• Device Operator: Health Professional
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention