MAUDE Adverse Event Report: UROCURE, LLC ARCTV TRANSVAGINAL SLING SYSTEM; URINARY SLING

Model Number A-TV-1001

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

After discussion with other physicians that perform mid-urethral sling surgeries, it was determined that the procedure most likely contributed to the sling twisting for the following reasons: the incision made by the surgeon in order to pass the suspension needle has likely been minimized by her choice of dissection technique.She also likely employs minimal dissection of the tunnel and relies on the suspension needle and sling-sheath to dilate the tract.The small size of the tract may be contributing to the rolling of the soft-sheath with arctv and when the sheath is removed, the edges of the mesh rolling/curling within the dissection tunnel and the incision site.Discussion with dr.(b)(6) cmo/urocure and other surgeons who perform this procedure confirmed that a larger incision and dissection tunnel facilitates in passing the soft-sling sheath with the mesh and after sheath removal allows the mesh to be situated flat below the incision and within the dissection tunnel.The incisions they made in recent surgeries were measured and they ranged from 1.2-1.5cm.Which are larger than the sling width.The incision with minimal dissection is often less than 1cm as is the tunnel made by the suspension needle and soft-sheath.Dr (b)(6) removed arctv sling during the same surgery because she couldn't get it to lie flat and replaced with a different sling.

Event Description

During a mid-urethral sling surgery, the mesh rolled longitudinally multiple times.The doctor removed the sling during the same surgery and replaced it with a different sling.

• Brand Name: ARCTV TRANSVAGINAL SLING SYSTEM
• Type of Device: URINARY SLING
• Manufacturer (Section D): UROCURE, LLC; 701 north 3rd st; suite 110; minneapolis, mn
• Manufacturer (Section G): BIOMERICS-ADVANCED CATHETER; 10351 xylong ave n #100; minneapolis, mn
• Manufacturer Contact: john nealon ; 701 north 3rd st; suite 110; minneapolis, mn ; 8506814
• MDR Report Key: 10462159
• MDR Text Key: 209029692
• Report Number: 3013859837-2020-00001
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/05/2020
• Initial Date FDA Received: 08/27/2020
• 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