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

Catalog Number EN2007030/B

Device Problems Fracture (1260); Material Separation (1562)

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

Event Date 08/26/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account alleges that during a ureteric stent removal procedure, the distal portion of a vascular snare device detached within the patient during the removal processes.The physician successfully externalized the foreign body with another vascular snare device liberating the vessel.The procedure was successfully completed for this patient.No additional consequences to report.

Manufacturer Narrative

The suspect device was returned for investigation.The device was examined visually and microscopically.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.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.

• 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; south jordan, UT 84095
• MDR Report Key: 15380222
• MDR Text Key: 299479733
• Report Number: 9616662-2022-00017
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 00884450452479
• UDI-Public: 884450452479
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151497
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EN2007030/B
• Device Lot Number: K2387461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• 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
• Patient Outcome(s): Required Intervention