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 02/06/2024

Event Type  Injury  

Event Description

According to the available information when placing the dynamic anchor, the loop of the suture was lost in his dissection plane and could not be retrieved and had to cut the suture.A new sling was placed successfully.

Manufacturer Narrative

The lot number was reviewed for complaint trend, non-conforming report, and capa.No ncs nor capa's 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.

Manufacturer Narrative

A partial altis sling was received for evaluation.Examination of the sling revealed straight edges in a ¿v¿ formation, indicating the static end of the mesh most likely was cut with a sharp instrumentation for removal.Examination of the detached dynamic suture revealed that the dynamic anchor, tensioner and suture loop were detached from the suture and were not returned with the device.Blood residue was noted on the mesh.The information received indicated that during implantation of the dynamic anchor, the suture loop was lost in the dissection plane which required the physician to cut the sling in order to remove it.Based on the information received and review of the returned components, quality concluded that it was a use error.Another sling was placed as per ifu and the outcome was successful.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 when placing the dynamic anchor, the loop of the suture was lost in his dissection plane and could not be retrieved and had to cut the suture.A new sling was placed successfully.

• 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: 18841790
• MDR Text Key: 336956313
• Report Number: 2125050-2024-00361
• 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: 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519650
• Device Lot Number: 9066450_5196502400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• 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
• Patient Outcome(s): Other