MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. MONARC SLING SYSTEM; SURGICAL MESH

Catalog Number 9000056

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation (2001)

Event Date 12/12/2013

Event Type  Injury  

Event Description

It was reported that while performing a monarc implantation surgery, during "needle pass on the patient's right side, the physician perforated the bladder 3 times (cysto performed each attempt and needle was seen in bladder on 3 different attempts).Case was aborted after third attempt.Patient's vaginal incision and groin incisions were closed and a foley catheter was left in for 7-14 days.Physician was going to retry surgery at a later date." no add'l patient complications have been reported in relation to this event.

Manufacturer Narrative

Should add'l info become available regarding this event, it will be re-evaluated and a f/u report will be sent.

• Brand Name: MONARC SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd., west; minnetonka MN 55343
• Manufacturer (Section G): AMS MEDICAL SYSTEMS IRELAND LIMITED; park - garrycastle, dublin road; athlone, westmeath ; EI
• Manufacturer Contact: sharon zurn, director ; 10700 bren rd., west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 3576825
• MDR Text Key: 4061867
• Report Number: 2183959-2013-01216
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/12/2013

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2016
• Device Catalogue Number: 9000056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR