MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ENSNARE STANDARD

Catalog Number	EN2006020/CNB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is 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 filter removal surgery, it was found the 3 ring tip of ensnare was cracked in patient body.A new ensnare to remove the defect tip.No other additional injury on patient.
Additional Manufacturer Narrative
The suspect medical device was returned for evaluation.The complaint was confirmed.The root cause was attributed to device manufacturing.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: ENSNARE STANDARD
• Common Device Name: ENSNARE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; ballybrit, galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 18991617
• Report Number: 9616662-2024-00015
• Device Sequence Number: 7540304
• Product Code: MMX
• UDI-Device Identifier: 00884450452462
• UDI-Public: 00884450452462
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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 Catalogue Number: EN2006020/CNB
• Device Lot Number: K2866626
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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