MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM EN SNARE®; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	00884450452424
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a balloon dilation procedure within the pulmonary artery through the femoral vein of a 1-year-old patient, the tip of the guidewire detached while the wire was withdrawn.A snare was used to removed the tip of the wire, after gripping the tip, resistance was felt and part of the snare wire detached and remained within the vessel.The procedure was completed with the tip of the wire and fragment of the snare left within the patient in the peripheral region of the lung.Physician does not consider remaining fragments to be life-threatening.
Additional 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®
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEM; parkmore business park west; ballybrit, galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEM; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 16811542
• Report Number: 9616662-2023-00005
• Device Sequence Number: 3034252
• Product Code: MMX
• UDI-Device Identifier: 00884450452424
• UDI-Public: 00884450452424
• Combination Product (Y/N): N
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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: 01/31/2024
• Device Model Number: 00884450452424
• Device Catalogue Number: EN1003004/JPA
• Device Lot Number: K2202063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 1 YR
• Patient Sex: Unknown