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

Catalog Number	MSWSTFA35260EX
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges the wire coating and the wire tip detached within a balloon that was used in the patient.Both the wire and balloon were removed together as a unit.No intervention needed.A new wire was used to complete this procedure.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed, and the root cause is 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: 20081529
• Report Number: 9616662-2024-00029
• Device Sequence Number: 15343821
• Product Code: DQX
• UDI-Device Identifier: 00884450529447
• UDI-Public: 00884450529447
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 08/23/2024

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 Catalogue Number: MSWSTFA35260EX
• Device Lot Number: K2888189
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 10/11/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/03/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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