MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND SPLASHWIRE¿.GUIDE WIRE; GAS CONTROL UNIT

Catalog Number	MSWSTDA35180
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device was discarded at the account and not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The account alleges that during preparation for a thrombectomy procedure when the guide-wire was back loaded onto a guide catheter, it was obvious that a clear reddish-thick gel was collecting on the guidewire.The device was not used or introduced into the patient's anatomy.No patient contact or injury to report.It is likley the wire did come into contact with blood somehow due to the alleged red color of the outer hydrophilic coating.The wire was discarded and will not be returning for device evaluation.

• Brand Name: SPLASHWIRE¿.GUIDE WIRE
• Common Device Name: GAS CONTROL UNIT
• 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 ; 8012088662
• MDR Report Key: 18988247
• Report Number: 9616662-2024-00012
• Device Sequence Number: 15506226
• Product Code: DTX
• UDI-Device Identifier: 00884450529669
• UDI-Public: 884450529669
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2024

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: MSWSTDA35180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACCESS SHEATH; GUIDECATHETER
• Patient Sex: Unknown