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

Model Number	M0068318200
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of torn mesh.
Event or Problem Description
It was reported during a sacrocolpopexy procedure, an upsylon y-mesh was used.When the mesh was grasped with the needle driver and inserted into the patient, it tore.The procedure was completed with another of the same device and no complications were reported for the patient.
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of torn mesh.Block h11: upon receipt at our quality assurance laboratory, this upsylon y-mesh underwent a thorough analysis.Visual inspection found that the mesh was torn.Based on the information available and analysis results, the reported allegation of the mesh torn material was confirmed through product analysis.A conclusion code of adverse event related to procedure was assigned to this investigation since it is likely that procedural conditions, such as user handling technique during placement of the mesh, resulted in the tearing of the mesh, indicates that the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported during a sacrocolpopexy procedure, an upsylon y-mesh was used.When the mesh was grasped with the needle driver and inserted into the patient, it tore.The procedure was completed with another of the same device and no complications were reported for the patient.

• Brand Name: UPSYLON
• Common Device Name: 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
• MDR Report Key: 21530644
• Report Number: 2124215-2025-13501
• Device Sequence Number: 20916582
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: (01)08714729839217(17)271024(10)C005034
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C005034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female