MAUDE Adverse Event Report: UROCURE ARCTV TRANSVAGINAL SLING SYSTEM

Model Number A-TV-1001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Urinary Retention (2119)

Event Type  Injury  

Event Description

The patient tolerated the initial procedure without problems except for a slow urinary stream and a feeling of incomplete emptying post-operatively.The patient voided without catheterization for 5-6 weeks and after discussion with her physician elected to have the sling "cut" in a minor surgical procedure.The indication was that the sling was 'too tight'.After "lysis" but without removal of the sling or any portion of the sling, the patient remained continent and resumed a normal voiding pattern.The operation was performed without additional adverse event / no urinary or systemic infection.

Manufacturer Narrative

Device was implanted in 2022 and the lysis of the sling was completed 10 weeks later.

• Brand Name: ARCTV TRANSVAGINAL SLING SYSTEM
• Type of Device: SLING
• Manufacturer (Section D): UROCURE; 701 north 3rd street; suite 110; minneapolis MN 55401
• Manufacturer (Section G): BIOMERICS - ADVANCED CATHETER; 10351 xylon ave n #100; minneapolis MN 55445
• Manufacturer Contact: denise lenz ; 701 north 3rd street; suite 110; minneapolis, MN 55401 ; 6129653445
• MDR Report Key: 15871918
• MDR Text Key: 304419614
• Report Number: 3013859837-2022-00001
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: A-TV-1001
• Device Catalogue Number: A-TV-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2022
• Initial Date FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Female