MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR SYSTEM; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number	519551 / 93-4400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Ambulation or Postural Difficulties (2544); Hematuria (2558); Genital Bleeding (4507); Pelvic Pain (4865)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.The device was not returned for evaluation.Without the benefit of analyzing the device, coloplast cannot comment on the condition of the device.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
According to the available information in mw5168334: "call received with complaint of urethral/vaginal sling failure.Reporter stated that sometime after the device was implanted, she started experiencing severe urinary tract infections and vaginal bleeding.Over time, these issues worsened to the point that she now has urinary retention (intermittent), pressure in her abdomen, abdominal/pelvic pain (constant), pain with movement, hematuria, and is frequently confined to her bed.She has recently had two pap smears: first one on (b)(6) 2024, and second one on (b)(6) 2025, and is scheduled to undergo a scope this coming friday ((b)(6) 2025).From her first pap smear, she learned that the sling material (wires) has adhered and grown into, and through, her vaginal wall approximately 1cm in length.Reporter stated that as of today, she has continuous vaginal bleeding which has an overall impact on her physical and mental health.
Additional Manufacturer Narrative
Correction: f1901 removed.The device was not returned for evaluation.However, because examination of the returned components may not conclusively confirm or disprove the report of the reported adverse events (adhesion, bleeding, erosion/exposure, pain, urinary retention, urinary tract infection, hematuria), quality accepts the initial reporter's observations of such as the reason for medical intervention.Complaints of this nature are monitored and captured within the product risk documentation except emotional changes and ambulation or postural difficulties.There are no clinical studies or literature to support a specific causal relationship between aris and emotional changes and ambulation or postural difficulties.The review of the device lot history record indicates this lot was processed through the validated sterilization cycle.Therefore, it was concluded the infection originated from source(s) other than the device.A review of the device history record 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: ARIS TRANSOBTURATOR SYSTEM
• Common Device Name: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21894981
• Report Number: 2125050-2025-00677
• Device Sequence Number: 3530882
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 519551 / 93-4400
• Device Lot Number: 6048610_5195512400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female