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

Catalog Number 72403656

Device Problems Sticking (1597); Material Deformation (2976)

Patient Problem Urinary Retention (2119)

Event Date 03/18/2015

Event Type  Injury  

Event Description

It was reported that the sparc sling system was being implanted when the "sheath overlap upon mesh stuck together and contorted mesh." the physician was able to reposition and re-tension the mesh and sparc sling was implanted.Following implant the patient experienced urinary retention.A surgery was performed the week of (b)(6) and the sling was loosened.There were no further patient complications reported in relation to this event and the patient is doing "well.".

• Brand Name: AMS SPARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath ; EI
• 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: 4660142
• MDR Text Key: 5622180
• Report Number: 2183959-2015-00138
• 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: 03/18/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/03/2017
• Device Catalogue Number: 72403656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2014
• 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): Hospitalization; Required Intervention