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 Device Dislodged or Dislocated (2923)

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

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report, and capa.No ncs nor capas were identified in veeva.There were several complaints identified against this lot; however, with various failure modes.Therefore, this is not considered a trend.Devices met specification prior to release.

Event Description

According to the available information, the anchor releases immediately without force during implantation.This error occurred 3 times in a row during the procedure utilizing 3 distinct devices from the same lot.No adverse effects to the patient were reported.

Manufacturer Narrative

An altis sling was returned for evaluation.Examination of the sling revealed the static anchor and suture were detached and not returned.Visual observation of the mesh where the static suture was attached confirmed the welded area of the suture was still attached.Microscopic examination of the mesh where the static anchor was attached revealed rough and irregular surfaces, indicating stress may have been exerted.The dynamic suture was still attached but the dynamic anchor, tensioner and suture loop were detached and not returned.Blood residue was noted on the mesh.The information received indicated the static anchor detached during the procedure.Quality confirmed the detached static anchor.As the static anchor and suture were not received, it was concluded that the detachment of the static anchor most likely occurred while placing the anchor through the obturator membrane.As the detachment ends of the static suture were rough and irregular, this indicated that excess stress was most likely exerted to result in the separation noted.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 anchor releases immediately without force during implantation.This error occurred 3 times in a row during the procedure utilizing 3 distinct devices from the same lot.No adverse effects to the patient were reported.

• 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: 18867243
• MDR Text Key: 337234588
• Report Number: 2125050-2024-00380
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05701780274807
• UDI-Public: 5701780274807
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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: 03/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/14/2024
• 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