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

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/14/2014

Event Type  Injury  

Event Description

It was reported that during implant of the monarc sling system, there was "very great difficulty to remove the plastic sheath" and that "the plastic that overlap in the central part is pasted." the sheath was removed "with great difficulty" in "several pieces." it is possible that a part of the sheath remained in the patient and that the surgeon "has to pull too much" in order to remove the device.The monarc sling was later explanted because the mesh was "too tight." in the physician's opinion the difficulty removing the sheath is related to the monarc explant.There were no additional patient complications reported in relation to this event.

Manufacturer Narrative

Lot and serial number was reported as (b)(4), however this is not a valid lot number for the monarc sling system.Capa (b)(4) was previously completed for "sheath halves grabbing together." an outcome of this investigation was the implementation of a slit in one sheath half to reduce force to separate sheaths.Verification testing conducted per this investigation demonstrated that slings with a slit in one sheath half separated more easily.

• Brand Name: AMS MONARC 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 (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 3693004
• MDR Text Key: 4301243
• Report Number: 2183959-2014-00090
• 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
• Report Date: 01/14/2014

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: 02/21/2014
• Initial Date FDA Received: 03/21/2014
• 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): Required Intervention