MAUDE Adverse Event Report: COLOPLAST CORP ALTIS KIT; SURGICAL MESH

Model Number 5196502400

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, defective device.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation and device received.An altis sling and introducers were received for evaluation.The sling was received with the static suture and anchor cut from the mesh and not returned.The dynamic suture was received although not attached to the mesh.The dynamic anchor was not received.When evaluating under a microscope, it was observed that the static suture and anchor were cut out to facilitate explant.The cut was perpendicular to the static suture to mesh weld and roughly halfway down the weld.Foreign blood residue was observed throughout indicating the device had been used in surgery.The mesh and dynamic suture to mesh weld were intact.The point at which the dynamic suture met the mesh experienced minimal fraying from the separated dynamic suture.The dynamic suture had torn away from the mesh at the suture to mesh junction.Quality contacted the cm to have dhr records reviewed.The cm confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no trends for this same lot number and failure mode.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.No patient injury was reported.Based on quality's examination, quality concluded that product meets specification however, examination of the implant confirmed that the static suture and anchor were cut, the dynamic anchor was missing, and that the dynamic suture had separated from the mesh at the suture to mesh junction.It was reported that the altis tensioning suture broke during placement; the cause of this could not be determined.

Event Description

Additional information stated tensioning suture broke during placement of sling.Removed and replaced during same procedure.The device was damaged to facilitate explant.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis MN 55411
• MDR Report Key: 8677237
• MDR Text Key: 147298498
• Report Number: 2125050-2019-00449
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6446615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 06/06/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR