MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS RETROARC RETROPUBIC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Device Problem Folded (2630)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2014

Event Type  Injury  

Event Description

It was reported that during a retroarc sling implant the "mesh rolled under urethra during implantation." it was noted that the ams representative noticed the sticky sheath and helped coach the physician on how to loosen the sheath during implant.She instructed the physician to apply enough pressure to the sheath to unstick the midline area.In the process of doing this the mesh was put under a large amount of tension causing a curling effect on the edge of the mesh.She coached the physician through the process of releasing the tension on the mesh and the mesh returned to the intended shape.The surgery was completed with the retroarc mesh in a good position.No patient complications were reported in relation to this event.

• Brand Name: AMS RETROARC RETROPUBIC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath ; EI
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 3710076
• MDR Text Key: 4264340
• Report Number: 2183959-2014-00101
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2014
• 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): Hospitalization; Required Intervention