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

Model Number 5196502400

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, during mid urethral sling portion of procedure altis was placed on the right side first.I 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 a small piece of metal (7 mm) from distal portion of left applicator was missing.Msi x-rays 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 KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 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: 7045426
• MDR Text Key: 92515894
• Report Number: 2125050-2017-00581
• 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: other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Device Lot Number: 5449719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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