MAUDE Adverse Event Report: AMS MINI ARC PRECISE

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/27/2015

Event Type  malfunction  

Event Description

Product did not secure itself to its anchor, and then was released and lost in the obturator muscle.It was necessary to place a second device, which functioned properly.Reason for use: stress urinary incontinence.

• Brand Name: MINI ARC PRECISE
• Type of Device: MINI ARC PRECISE
• Manufacturer (Section D): AMS
• MDR Report Key: 5064181
• MDR Text Key: 25281744
• Report Number: MW5056039
• Device Sequence Number: 1
• Product Code: PAH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1