MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COLPASSIST; MESH, SURGICAL, SYNTHETIC

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

Patient Problem Insufficient Information (4580)

Event Date 03/15/2021

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 implant date.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: imdrf patient code e2401 captures the reportable event of an unspecified personal injury.Impact code f12 has been used in the light of the patient seeking legal recourse for an unspecified personal injury related to the device.

Event Description

It was reported to boston scientific corporation that a mesh device was implanted during a robotic-assisted sacro colpopexy, cystoscopy, excision of exposed sub urethral mesh procedure performed on (b)(6) 2021, for the treatment of vaginal prolapse with cystocele and exposed sub urethral mesh.As reported by the attorney, the patient experienced an unknown injury.Additional details regarding this experience were not provided.

Event Description

It was reported to boston scientific corporation that a mesh device was implanted during a robotic-assisted sacro colpopexy, cystoscopy, excision of exposed sub urethral mesh procedure performed on march 15, 2021, for the treatment of vaginal prolapse with cystocele and exposed sub urethral mesh.As reported by the attorney, the patient experienced an unknown injury.Additional details regarding this experience were not provided.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of march 15, 2021, was chosen as the best estimate based on the implant date.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).(b)(6) medical.Block h6: imdrf patient code e2401 captures the reportable event of an unspecified personal injury.Impact code f12 has been used in the light of the patient seeking legal recourse for an unspecified personal injury related to the device.

• Brand Name: COLPASSIST
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach, spiddal; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17725507
• MDR Text Key: 323149136
• Report Number: 3005099803-2023-04794
• Device Sequence Number: 1
• Product Code: KOH
• 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
• 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

• Date FDA Received: 09/11/2023
• 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
• Date Manufacturer Received: 04/24/2024
• 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): Other
• Patient Age: 55 YR
• Patient Sex: Female