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

Catalog Number 9000252

Device Problem Sticking (1597)

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

Event Date 09/24/2014

Event Type  malfunction  

Event Description

It was reported that during an initial implant of a retroarc sling, the scrub tech pulled the sheaths apart per instructions which made a very clear and loud audible snap sound indicating the sheaths were clearly stuck together.The sheaths were independently moving when the physician implanted the sling.He cut the sheaths covering the sling well below the blue dots after it was implanted.The physician grabbed both sheaths and pulled.The right sheath stuck to the mesh so hard that it pulled through the patient's left skin incision and out the other side, so a majority of the sling pulled through the other incision.The sling was still under the urethra; however, upon review the physician decided to removed the sling and replace with another retroarc for the desired outcome.No patient injury or 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: 4153092
• MDR Text Key: 4789736
• Report Number: 2183959-2014-00446
• 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: 09/24/2014

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 Expiration Date: 11/05/2016
• Device Catalogue Number: 9000252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2013
• 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