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

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

Patient Problems Erosion (1750); Pain (1994); Abnormal Vaginal Discharge (2123); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2006 captures the reportable event of erosion of mesh.Imdrf patient code e1401 captures the reportable event of abnormal vaginal discharge.Imdrf patient code e1405 captures the reportable event of pain with intercourse.Imdrf impact code f1202 captures the reportable event of quality of life affected.

Event Description

It was reported that the patient underwent a y-mesh implant for the treatment of stress urinary incontinence.Approximately five years after placement, the patient experienced erosion through the vaginal wall.Additionally, the patient noted pain, abnormal discharge, lack of urinary control and pain with intercourse as a result.Conservative treatment options have been attempted to no avail, including vaginal estrogen, suturing, and abstinence.The patient indicated looking for a physician to remove the device.No additional information was reported.

Manufacturer Narrative

Correction to blocks b5, d1, d2a, d2b and g1.Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2006 captures the reportable event of erosion of mesh.Imdrf patient code e1401 captures the reportable event of abnormal vaginal discharge.Imdrf patient code e1405 captures the reportable event of pain with intercourse.Imdrf impact code f1202 captures the reportable event of quality of life affected.

Event Description

It was reported that the patient underwent a mesh tension-free vaginal tape implant for the treatment of stress urinary incontinence.Approximately five years after placement, the patient experienced erosion through the vaginal wall.Additionally, the patient noted pain, abnormal discharge, lack of urinary control and pain with intercourse as a result.Conservative treatment options have been attempted to no avail, including vaginal estrogen, suturing, and abstinence.The patient indicated looking for a physician to remove the device.No additional information was reported.

• Brand Name: COLPASSIST
• 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: 19122090
• MDR Text Key: 340337388
• Report Number: 2124215-2024-22406
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2024
• 2 Devices were Involved in the Event: 1 2

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability; Required Intervention
• Patient Sex: Female