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

Model Number 5196502400

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Event Description

According to available information, after inserting this device and tensioning it, the plastic arrow of the dynamic anchor broke in half at the suture, leaving half of it in the obturator fossa, and the sling detached.The static anchor was implanted but was subsequently removed because the dynamic anchor failed.Another altis was successfully implanted, and patient is doing well with no ill effects.

Manufacturer Narrative

An altis sling was received for evaluation.The static anchor was attached to the sling.The static anchor tines were bent outward, indicating the anchor had been implanted and removed.The dynamic suture and tensioner were attached, but the dynamic anchor was not received.Blood residue was noted on all returned components.The information received indicated the dynamic anchor detached during the tensioning of the sling.During placement of the anchor onto the introducer tip, or during removal of the introducer after placement, the dynamic anchor may have shifted inside the tensioner.If this were to have occurred the dynamic anchor may not have held in position as expected which may have resulted in the detachment reported.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11329940
• MDR Text Key: 232005943
• Report Number: 2125050-2021-00130
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6820292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Date Manufacturer Received: 06/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR