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

Model Number 5196502400

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, additional information received on during the altis procedure the physician had a very aggressive cephalad drift motion while trying to implant the static anchor.She heard a significant ¿pop¿ and much of the sling was showing, which the territory manager indicated that most likely the static anchor was placed in front of the bone.The decision was made to remove the sling, which included the static anchor.After removal it was noted that the tip of one introducer was detached.A urogynecologist was consulted and joined the procedure.An x-ray was done and confirmed that the introducer tip remained in the patient.A magnet was used to try and extract the introducer tip, but it did not work, tip is stainless steel.Determination in the procedure was that the detached tip was most likely embedded in muscle.The physician did not attempt to implant a second sling.The physician implanted altis during her residency, but few since.Add'l info rec'd 10/11/2021: after the pop she proceeded to do the 1/4inch rotation and then deployed the trocar.After trocar deployment it was noticed that the anchor may not have been inserted into the proper space so the physician pulled the sling mesh and the anchor came down.Upon attempting to reload the static anchor onto the trocar it was noticed that the trocar tip had broke off and was not inside of the static anchor.X-ray was brought in and showed that the trocar tip was indeed inside the patient.After several unsuccessful attempts to remove the trocar tip from the patient it was decided by the surgical team to leave the tip behind and not attempt any further aggressive excision routes.There was roughly a 90-minute attempt including x-ray to extract the trocar tip.No other adverse patient effects were reported.

Manufacturer Narrative

An altis sling and two introducers were received for evaluation.Examination of the sling revealed no abnormalities.Both anchors and sutures were attached and intact.Examination of the introducers revealed the tip of the left introducer to be detached and not returned.Microscopic examination of the detachment end revealed the surfaces to be rough and irregular, indicating stress was exerted.No functional abnormalities were noted with the right introducer.Blood residue was noted on the sling and both introducers.Based on the information received, the physician had some difficulties correctly placing the sling during the first attempt and ended up removing the sling.When the sling was removed from the patient that was when the detached introducer tip was noticed.The physician tried to remove the detached tip from the patient but was unsuccessful.Examination of the returned components confirmed the detached introducer tip.Review of the introducer tip by a principal r&d engineer concluded that the physician may have not pushed towards the descending ramus enough during the cephalad push and bent the tip towards herself.Based on the information received, and examination of the returned components, it was concluded that the detached introducer tip was most likely a result of incorrect placement of the sling during the procedure.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
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12701050
• MDR Text Key: 278607634
• Report Number: 2125050-2021-01545
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 7243988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female