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

Catalog Number	MSWSTFS35260EX
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2024
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 the black jacket of the wire peeled off in the patient while using a trailblazer catheter and still remains within the patient.The patient vitals are currently stable.No additional information to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed, and the root cause could not be established; however, it is most likely attributed to clinical use and excessive force during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• 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: 19510732
• Report Number: 9616662-2024-00021
• Device Sequence Number: 11627056
• Product Code: DQX
• UDI-Device Identifier: 00884450529591
• UDI-Public: 00884450529591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/30/2024

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 Expiration Date: 06/30/2026
• Device Catalogue Number: MSWSTFS35260EX
• Device Lot Number: K2829680
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown