MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD. ENSNARE ENDOVASCULAR SNARE SYSTEM; ENDOVASCULAR SNARE SSTEM

Catalog Number EN2006020/A

Device Problem Material Separation (1562)

Patient Problems Injury (2348); Needle Stick/Puncture (2462)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a biliary stent retrieval procedure the snare was damaged.When the physician removed the snare from the patient he inadvertently punctured his thumb on the damaged portion of the snare device.The damage was alleged to be at the at the distal junction weld from which all three snare loops protrude.The physician was tested for blood born pathogen exposure per hospital policy and received minor first aid for his wound.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the complaint database was performed and no similar complaints were found for this lot number.A review of the device history record was performed and no exception documents were found.

• Brand Name: ENSNARE ENDOVASCULAR SNARE SYSTEM
• Type of Device: ENDOVASCULAR SNARE SSTEM
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; ballybrit, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; ballybrit, ; EI
• Manufacturer Contact: casey hughes ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6558167
• MDR Text Key: 74853013
• Report Number: 9616662-2017-00015
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: EN2006020/A
• Device Lot Number: K1070354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• 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