MAUDE Adverse Event Report: Covidien MICROSNARE; CATHETER, PERCUTANEOUS

Catalog Number	SK401
Medical Device Problem Codes	Nonstandard Device (1420); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction

• Brand Name: MICROSNARE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): Covidien; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): Covidien; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50432431
• Report Number: 2183870-2026-00404
• Device Sequence Number: 9178016
• Product Code: DQY
• UDI-Device Identifier: 00763000225407
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K970668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: SK401
• Device Lot Number: B228948
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown