MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS RETROARC RETROPUBIC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 9000262

Device Problem Separation Failure (2547)

Patient Problem Urinary Retention (2119)

Event Date 12/11/2015

Event Type  Injury  

Event Description

It was reported that following the implantation of a retroarc sling, the patient experienced high residuals and was discharged with a catheter.It was also noted that during the procedure, the sheath was sticking to the sling.The sheath "eventually came off".There were no further patient complications reported in relation to this event.

• Brand Name: AMS RETROARC RETROPUBIC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASTORA WOMEN'S HEALTH LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer (Section G): ASTORA WOMEN'S HEALTH (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath ; EI
• Manufacturer Contact: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5341994
• MDR Text Key: 34985766
• Report Number: 3011770902-2016-00007
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/16/2015

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: Health Professional
• Device Expiration Date: 05/21/2018
• Device Catalogue Number: 9000262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2015
• 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
• Patient Age: 51 YR