MAUDE Adverse Event Report: ARGON MEDICAL DEVICES GUIDEWIRE (DIAMETER .035" X LENGTH 150CM)

Model Number	A395231
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
During procedure, a physician stopped using the guidewire as the guidewire soft tip(distal tip) was abnormally stiffer than usual.The procedure was completed by using an additionally opened replacement (a395231).
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
During procedure, a physician stopped using the guidewire as the guidewire soft tip(distal tip) was abnormally stiffer than usual.The procedure was completed by using an additionally opened replacement (a395231).
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no abnormal occurrences were found.One unsealed sample was returned to argon from the customer for inspection.A dimensional analysis was performed on the returned sample.The dimensional analysis determined that the cores of the guidewire were out of specification.The o.D.On both ends of the core of the guidewires were over-tolerance.This could lead the guidewire to have a stiffer end than normal.It is possible that the operator used this part as a set up part and did not dispose of it properly before continuing process.This was likely unnoticed by the operator during the process.At this time, the issue does not appear to be systemic so this will be treated as an isolated issue.However, argon will continue to monitor for recurrence.
Event or Problem Description
During procedure, a physician stopped using the guidewire as the guidewire soft tip(distal tip) was abnormally stiffer than usual.The procedure was completed by using an additionally opened replacement ((b)(6)).
Additional Manufacturer Narrative
Corrected information provided in d.4.And g.4.Due to an error in the previous mdr.

• Brand Name: GUIDEWIRE (DIAMETER .035" X LENGTH 150CM)
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18003495
• Report Number: 0001625425-2023-01233
• Device Sequence Number: 6642847
• Product Code: DQX
• UDI-Device Identifier: 00886333216215
• UDI-Public: (01)00886333216215(17)280303(10)11467020
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/19/2024

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 Model Number: A395231
• Device Lot Number: 11467020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 10/12/2023; 06/13/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 12/15/2023; 01/20/2024; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown