MAUDE Adverse Event Report: COLOPLAST A/S ALTIS; SINGLE INCISION SLING SYSTEM

Catalog Number 519650

Device Problems Loose or Intermittent Connection (1371); Difficult To Position (1467); Device Or Device Fragments Location Unknown (2590)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 10/09/2017

Event Type  malfunction  

Event Description

During mid urethral sling portion of procedure, altis was placed on the right side first.In attempt for left side placement, some difficulty was encountered.After it was thought anchor was placed properly, applicator was removed with minimal difficulty.Anchor was noted to be loose and came out with applicator.A second device was then opened (since initial left anchor came out).Existing sling removed and right anchor remained in situ.It was then noted small piece of metal (7mm) from distal portion of left applicator was missing.Msi xrays pelvis and abdomen 2 view noted vaginal packing, but no other radiopaque foreign body was seen.Surgeon made decision not to attempt placement of another mid urethral sling at this time.

• Brand Name: ALTIS
• Type of Device: SINGLE INCISION SLING SYSTEM
• Manufacturer (Section D): COLOPLAST A/S; humlebaek, dk ; DA
• MDR Report Key: 6951014
• MDR Text Key: 89501013
• Report Number: MW5072762
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 5708932467407
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/12/2017

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 Expiration Date: 02/06/2020
• Device Catalogue Number: 519650
• Device Lot Number: 5449719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 79