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

Model Number 5196502400

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

Two introducers were received for evaluation.Examination of the left introducer revealed the tip to be detached.Microscopic examination of the detached end of the left introducer revealed the detachment site to be rough and irregular, indicating stress was exerted.Examination of the right introducer revealed the tip was bent, but still attached.Blood residue was noted on both introducers.Examination confirmed the detached tip from the left introducer, and also confirmed the tip of the right introducer to be bent, but still attached.No information was received as to the events leading up to the bent tip on the right introducer.The introducer tip may bend, or eventually detach, if it is pushed onto something hard such as bone, which indicates the introducer may not have been in the proper place to insert the anchor.The lot number was reviewed for complaint trend, nonconforming report and capa.The devices met specification prior to release and no trends were noted.

Event Description

According to the available information, the tip of the trocar broke off while attempting to implant the mesh.The physician placed the anchor on the patient¿s right side; while placing the anchor and experiencing the proper implanting experiences, there was some difficulty removing the trocar (it ¿felt stuck¿).Finally, the physician was able to remove it, but noticed that the tip was missing from the trocar.The tip was unable to be located, however, x-ray identified the tip inside the patient.The sling was successfully placed and tensioned.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15305163
• MDR Text Key: 298762446
• Report Number: 2125050-2022-00831
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2022

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 Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 8069226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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 Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Female