MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH

Model Number 5196501022

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation (2001)

Event Date 07/21/2016

Event Type  Injury  

Event Description

According to the information received, there was a lack of guide for introducing the mesh so there was perforation of the vaginal wall.It was impossible to go back and section the anchor.There were no observed clinical consequences.It was user error and there had never been a guide with altis.The urologist took the vaginal cul-de-sac and perforated the vaginal wall.He sewed the wall and implanted another altis.

Manufacturer Narrative

One altis sling and two introducers were received for evaluation.Evaluation of the returned components was not performed, as it was reported that use error of the device was the root cause of the device failure.It was noted that the static anchor was cut away from the sling, indicating it was the anchor that was incorrectly placed into the vaginal wall.The introducer is designed to deliver the anchor to the desired location in the obturator internus muscle, however if the surgical steps laid out in the ifu are not followed, the anchor can be incorrectly placed.In this case, either the cephalad drift, prior to turning the introducer, was not performed, or the introducer was not held parallel to the descending ramus as instructed in the ifu, resulting in the anchor being implanted in the vaginal wall instead of the obturator internus.It cannot be conclusively determined exactly which step was not followed based on the provided information, however both are instances of use error (iatrogenic use) since the ifu steps were not followed.It was concluded that this use error was the root cause of the reported event.This complaint was forwarded to the contract manufacturer (cm) for review.The cm reviewed the manufacturing records for lot 4944763 to verify that there were no discrepancies and confirmed that all devices from the lot met specifications.The full cm response and lot certification record is attached to this complaint.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5953619
• MDR Text Key: 54874070
• Report Number: 2125050-2016-00221
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5196501022
• Device Catalogue Number: 5196501022
• Device Lot Number: 4944763
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other