MAUDE Adverse Event Report: MERIT MEDICAL ENSNARE

Catalog Number EN2006020-S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/14/2014

Event Type  Injury  

Event Description

Ensnare in use to retrieve ivc filter, attached to filter and broke after minimal pressure placed on it.

• Brand Name: ENSNARE
• Type of Device: SNARE
• Manufacturer (Section D): MERIT MEDICAL
• MDR Report Key: 3731291
• MDR Text Key: 4307394
• Report Number: 3731291
• Device Sequence Number: 1
• Product Code: MMX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2014
• Device Catalogue Number: EN2006020-S
• Device Lot Number: K277367
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR