MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND SPLASHWIRE¿.GUIDE WIRE; GUIDEWIRES

Catalog Number	MSWSTFA35260EX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that when inserting the hydrophilic guidewire through an access sheath, the clear hydrophilic coating was gathering in front of the valve.The sheath was removed, and the clear coating that collected was flushed from the sheath.
Additional Manufacturer Narrative
Unopened units from the same lot were returned for evaluation.Two units were evaluated and confirmed to have the same coating buildup as reported in the complaint.The complaint is confirmed.A root cause could not be determined.Corrective actions are in process.A review of the device history record was performed and one similar exception document was identified.Relation to the complaint is under investigation.A review of the complaint database was performed and no similar complaints from this lot number were identified.

• Brand Name: SPLASHWIRE¿.GUIDE WIRE
• Common Device Name: GUIDEWIRES
• Manufacturer (Section D): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit,; galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit,; galway ; EI
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18889719
• Report Number: 9616662-2024-00011
• Device Sequence Number: 11512462
• Product Code: DQX
• UDI-Device Identifier: 00884450529447
• UDI-Public: 884450529447
• 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): 03/04/2024

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: 09/16/2026
• Device Catalogue Number: MSWSTFA35260EX
• Device Lot Number: K2790383
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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