MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD SPLASHWIRE¿ GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number	MSWSTFA35260EX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
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 the access sheath had to be removed from the patient because of coating of the access guidewire was collecting at the sheath valve.After sheath removal, the clear gelatinous material was flushed from the access sheath/sheath valve.No patient injury to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and the complaint is confirmed.No definitive root cause could be determined.Corrective actions are in process.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and one similar complaint for this lot number were identified.

• Brand Name: SPLASHWIRE¿ GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 18789789
• Report Number: 9616662-2024-00010
• Device Sequence Number: 20916114
• Product Code: DQX
• UDI-Device Identifier: 00884450529447
• UDI-Public: 00884450529447
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K201595
• 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): 02/21/2024

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: 07/31/2026
• Device Catalogue Number: MSWSTFA35260EX
• Device Lot Number: K2829676
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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
• Patient Sex: Unknown