MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS EN SNARE®.; PERCUTANEOUS RETRIEVAL DEVICE

Catalog Number EN2007030/CNB

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2021

Event Type  malfunction  

Event Description

The account alleges that during a vascular procedure involving a snare device, when retrieving the vascular snare from within the catheter, they also retrieved some type of transparent foreign material as well.It is currently unknown if any of the foreign material had been inadvertently introduced into the patient during use.The material in question is not radiopaque.The patient was discharged as expected with no additional consequences to report.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: EN SNARE®.
• Type of Device: PERCUTANEOUS RETRIEVAL DEVICE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 13370308
• MDR Text Key: 289083848
• Report Number: 9616662-2022-00001
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 00884450452479
• UDI-Public: 884450452479
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EN2007030/CNB
• Device Lot Number: K2210058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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