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

Catalog Number 9000059

Device Problems Material Frayed (1262); Difficult to Remove (1528); Sticking (1597); Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Date 07/24/2014

Event Type  Injury  

Event Description

It was reported that during a monarc sling implantation the plastic sheaths "stuck together." when the physician "pulled up on sheaths, he had to do so with such force that the sling over-tensioned and frayed so he removed the sling and placed another." no patient complications have been reported in relation to this event.

Manufacturer Narrative

The complete monarc sling device was returned and visually inspected.Both handle/needles were returned with the sling/sheath ends attached.The sling and sheath ends were both cut in the normal location to implant the sling.The sling otherwise appears normal.The sheath pieces have apparent tool marks where they were pulled off the sling.There is a scratched/abraded area approximately 1 cm x 2 mm on one sheath piece where they overlap.Unable to determine if this is related to the complaint of sticking sheath pieces.Analysis results were undetermined and no conclusion can be drawn.

• Brand Name: AMS MONARC 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: 4027881
• MDR Text Key: 18063665
• Report Number: 2183959-2014-00376
• 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: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/13/2015
• Device Catalogue Number: 9000059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2014
• 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