MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC ENSNARE ENDOVASCULAR SNARE SYSTEM

Catalog Number EN2006020/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account reported that a loop of the snare broke off inside the catheter and was left inside the patient.An arteriotomy was performed and the fragment was retrieved.

Manufacturer Narrative

One device was returned for evaluation.The product was examined visually.The complaint is confirmed.No definitive root cause could be determined however, it is likely that significant force was applied to the device.A search of the complaint data base found one similar complaint for this lot number from the same customer.The device history record was reviewed and no exception documents were found.

• Brand Name: ENSNARE ENDOVASCULAR SNARE SYSTEM
• Type of Device: ENDOVASCULAR SNARE SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6281486
• MDR Text Key: 65896556
• Report Number: 9616662-2017-00003
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• PMA/PMN Number: K151497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: EN2006020/A
• Device Lot Number: K947991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• 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