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

Device Problem Unstable (1667)

Patient Problem Perforation (2001)

Event Date 02/07/2014

Event Type  Injury  

Event Description

It was reported that the physician perforated the patient's urethra during the initial implant of an ams retroarc sling.The physician indicated that he was, "surprised by the lack of stability of the needle in the handle." no further patient complications were reported in association with this event.

Event Description

Additional information was provided on (b)(6) 2014 that indicated the physician did note movement with the handle/needle of the retroarc device.However, it was reported that he did not believe that was the reason for the urethral perforation associated with this event.It was also reported that the physician noted the patient had been operated on several times, sclerotic conditions were noted with the patient's tissue.The physician held the retroarc device by using the handle, there was no note of the physician using his finger to guide the needle during insertion.The physician noticed the urethral perforation at the beginning of the procedure and it was indicated that the first part of the anterior urethra was perforated.The urethra was repaired and the procedure was completed.The physician did use a catheter during the procedure.No additional patient complications were reported.

• 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: 3630678
• MDR Text Key: 3990050
• Report Number: 2183959-2014-00037
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 02/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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