MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. TRUE FORM¿..014 GUIDE WIRE; FG.GUIDEWIRES

Catalog Number	TF14180S/A
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that when trying to advance a microcatheter over a guidewire into the tibial artery under fluoroscopy, the tip of the guidewire detached.The guidewire tip and the microcatheter were successfully removed from the patient together, without additional medical intervention.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect medical device will not be returning for engineering evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Additional Manufacturer Narrative
The suspect medical device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: TRUE FORM¿..014 GUIDE WIRE
• Common Device Name: FG.GUIDEWIRES
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16242301
• Report Number: 1721504-2023-00005
• Device Sequence Number: 6408468
• Product Code: DQX
• UDI-Device Identifier: 00884450297896
• UDI-Public: 884450297896
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K170532
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2023

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: 12/31/2023
• Device Catalogue Number: TF14180S/A
• Device Lot Number: H2279360
• 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: 01/14/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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: INTERVENTIONAL GUIDE CATHETER; INTERVENTIONAL MICROCATHETER
• Patient Sex: Unknown