MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 720191-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 12/10/2015

Event Type  Injury  

Event Description

It was reported that after the implant of a miniarc precise, the patient experienced incidental cystotomy during dissection near the left vaginal apex.The cystotomy was repaired, and a cystoscopy confirmed that there was water tight repair of the bladder.The patient was hospitalized as an inpatient.The event was considered recovering/resolving.No further patient complications were reported in relation to this event.Related to mfr # 3011770902-2015-00078.

Manufacturer Narrative

Date rec'd should have been 01/20/2016, not 01/20/2015.

• Brand Name: AMS MINIARC PRECISE SINGLE-INCISION 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: 5315199
• MDR Text Key: 34007105
• Report Number: 3011770902-2015-00079
• Device Sequence Number: 1
• Product Code: PAH
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 720191-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/20/2016; 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2015
• 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): Hospitalization; Required Intervention