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

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Blocks 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 h6: imdrf device code a0414 captures the reportable event of mesh torn.

Event Description

It was reported to boston scientific corporation that a y-mesh was opened during a procedure performed.During intraoperative work, the y-mesh has frayed vertically two to three times since the physician started using it in (b)(6) 2023.A photo is attached showing the mesh torn vertically.It was not reported how the procedure was completed.

Event Description

It was reported to boston scientific corporation that an upsylon was opened during a sacrocolpopexy procedure performed.During intraoperative work, the y-mesh has frayed vertically two to three times since the physician started using it in (b)(6) 2023.A photo was provided showing the mesh torn vertically.It was not reported how the procedure was completed.Additional information received on november 2, 2023: the mesh was not torn in halves; instead, there was a tear present in the middle of the mesh.The procedure was completed with the original device.There were no patient complications as a result of the event.

Manufacturer Narrative

Block h11: information on how the procedure was completed, patient complications, and upn have been obtained via additional information, therefore, blocks b5 and d4 have been updated.Upon further review, the manufacturer became aware of the event on october 2, 2023, therefore, block b3 has been updated.Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.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 h6: imdrf device code a0414 captures the reportable event of mesh torn.

• 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: 17991016
• MDR Text Key: 327625030
• Report Number: 3005099803-2023-05591
• Device Sequence Number: 1
• Product Code: KOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• 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