MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; MESH, SURG, SYNTH, UROGYN, FOR STRESS URINARY INCONT, FEMALE, MINI-SLING

Model Number 519650

Device Problems Break (1069); Defective Device (2588)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

During procedure application of altis sling was deployed into patient.One of the anchors for the sling broke off inside of the patient resulting in device failure.Sling was cut off.Anchor remained in the patient.New altis device was used and deployed successfully.Defective device was removed from the sterile field and placed in bag for return to coloplast sales representative.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: MESH, SURG, SYNTH, UROGYN, FOR STRESS URINARY INCONT, FEMALE, MINI-SLING
• Manufacturer (Section D): COLOPLAST A/S; 1601 west river road north; minneapolis MN 55411
• MDR Report Key: 13964408
• MDR Text Key: 288291914
• Report Number: 13964408
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2022

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 Model Number: 519650
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Female