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

Catalog Number 9000060

Device Problem Separation Failure (2547)

Patient Problem Failure of Implant (1924)

Event Date 06/09/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent a sparc implantation procedure which resulted in a prolonged surgery time and the passing of two additional needles to implant another sling.It was indicated that the physician passed the sling needles and performed a cystoscopy.The sling was then connected to the trocars and the sling was pulled in place suburethrally.Upon placing hemostats on the plastic sheaths, the physician was unable to remove the sheaths.The plastic tore and the sheath would not release.The physician removed the sling and implanted another sling.No additional patient complications have been reported in relation to this event.

• Brand Name: AMS SPARC 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: 3902872
• MDR Text Key: 4429999
• Report Number: 2183959-2014-00257
• 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: 06/09/2014

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: 02/17/2017
• Device Catalogue Number: 9000060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2014
• 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