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 Detachment of Device or Device Component (2907)

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

Event Date 08/14/2023

Event Type  malfunction  

Event Description

According to available information, this device broke.As the device was being loaded, the short end anchor on the left side broke off.No other adverse patient effects were reported.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Manufacturer Narrative

An altis sling and two introducers were received for evaluation.Examination of the sling revealed the static anchor detached from the mesh and not received.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 static suture where the anchor had detached revealed rough and irregular surfaces, indicating stress may have been exerted.The dynamic suture was still attached to the mesh as received, along with the dynamic anchor & tensioner.No blood residue was noted on the sling or introducers.No abnormalities were noted with the introducers.The information received indicated the static anchor detached prior to implantation.Quality confirmed the detached static anchor.As no blood residue was noted on the sling or introducers, it was concluded that the detachment of the static anchor most likely occurred when the static anchor was being loaded on the introducer.As the detachment ends of the static suture were rough and irregular, this indicated that excess stress 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 available information, this device broke.As the device was being loaded, the short end anchor on the left side broke off.No other adverse patient effects 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: 17908934
• MDR Text Key: 325348030
• Report Number: 2125050-2023-01217
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932431484
• UDI-Public: 5708932431484
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 04/25/2024

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: Lay User/Patient
• Device Catalogue Number: 519650
• Device Lot Number: 8540192_5196501022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• 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