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 Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report, and capa.No ncs nor capas were identified.Devices met specification prior to release.

Event Description

According to the available information there was an issue with the altis device during implant.It was thought that the anchor was not in the membrane so it was removed.Upon observation the tip was observed to be broken off and lodged in the anchor.It was stated that bone was not hit, nor friction felt when inserting the introducer.

Manufacturer Narrative

An altis sling and one introducer were received for evaluation.Examination of the right introducer revealed the tip to be detached.Microscopic examination of the detachment end of the right introducer revealed the detachment site to be rough and irregular, indicating stress was exerted.Blood residue was noted on the introducer and the sling.No abnormalities were noted with the sling.The information received indicated that the introducer tip was broken during the procedure.Quality confirms the detachment site to be rough and irregular, indicating stress was exerted.The introducer tip may bend, or eventually detach, if it is pushed onto something hard such as bone, which indicates the introducer may not have been in the proper place to insert the anchor.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 there was an issue with the altis device during implant.It was thought that the anchor was not in the membrane so it was removed.Upon observation the tip was observed to be broken off and lodged in the anchor.It was stated that bone was not hit, nor friction felt when inserting the introducer.

• 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: 18237833
• MDR Text Key: 329375389
• Report Number: 2125050-2023-01500
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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: 8104590_5196502400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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
• Patient Age: 57 YR