MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number 519650

Device Problem Fracture (1260)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.

Event Description

According to the available information the string with loop broke.When tensioning, the anchor broke off.

Manufacturer Narrative

Further examination of the mesh confirmed the welded area of the dynamic suture had delaminated / detached completely from the mesh itself.Blood residue was noted on the mesh.Based on the information received and review of the returned components, quality confirmed that the dynamic suture detached from the mesh.Review of the mesh revealed the entirety of the dynamic suture including the welded area had detached fully from the mesh, with no suture still attached to the mesh.The full delamination of the suture from the mesh indicates that excess stress was exerted to result in the observed separation.As the dynamic anchor and tensioner were not received, it was concluded that the detachment of the dynamic suture most likely occurred during the tensioning part of the procedure.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

Event Description

According to the available information the string with loop broke.When tensioning, the anchor broke off.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18651045
• MDR Text Key: 334659725
• Report Number: 2125050-2024-00190
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 519650
• Device Lot Number: 9066451_5196504022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• 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