MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH, LLC MINIARC; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEM

Catalog Number 720191-01

Device Problems Stretched (1601); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2016

Event Type  malfunction  

Event Description

In the process of placing the sling, it became over stretched while the surgeon was trying to place the second anchor.It was removed and a solex sling was placed.Per operating room manager, the sling was torn/ripped.

• Brand Name: MINIARC
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEM
• Manufacturer (Section D): ASTORA WOMEN'S HEALTH, LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• MDR Report Key: 5793578
• MDR Text Key: 49505339
• Report Number: 5793578
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 720191-01
• Device Lot Number: 949214
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 55 YR
• Patient Weight: 96