MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS EN SNARE; PERCUTANEOUS VASCULAR SNARE

Catalog Number	EN2007030/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during an inferior vena cava filter removal procedure on a referral patient, the tip of a vascular snare device detached within the patients ivc.A second vascular snare device was prepped and deployed in attempts to remove the primary foreign body from the patient when the tip of the second snare device also detached.The physician states that usual resistance was experienced during the removal procedure even though the filter was embedded within the wall of the ivc.Original implant date in unknown.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause was attributed to use of the device contrary to the indications.A search of the complaint database was performed and one similar complaint for this lot number was found.The device history record was reviewed and no exception documents were found.

• Brand Name: EN SNARE
• Common Device Name: PERCUTANEOUS VASCULAR SNARE
• 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: 13588639
• Report Number: 9616662-2022-00004
• Device Sequence Number: 5913331
• Product Code: MMX
• UDI-Device Identifier: 00884450452479
• UDI-Public: 884450452479
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K151497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2024
• Device Catalogue Number: EN2007030/B
• Device Lot Number: K2254244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown