MAUDE Adverse Event Report: ARGON MEDICAL DEVICES GUIDEWIRE

Model Number	A395231
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
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.A physician is very concern about the abnormally stiff tip(distal tip) which was similar stiffness to the proximal stiff tip.The abnormally stiff tip (distal tip) can cause serious incident such as cardiac perforation on clinical use.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 deviations or non-conformances 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 one side of the guidewire was out of specification.The o.D.On one of the end of the distal end of the guidewire was over-tolerance.This could lead the guidewire to have a stiffer end than normal.It is likely that the operator only tapered the guidewire partially and removed the wire from the grinder prematurely.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.A physician is very concern about the abnormally stiff tip(distal tip) which was similar stiffness to the proximal stiff tip.-the abnormally stiff tip(distal tip) can cause serious incident such as cardiac perforation on clinical use.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
• 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: 17915064
• Report Number: 0001625425-2023-01226
• Device Sequence Number: 6627068
• Product Code: DQX
• UDI-Device Identifier: 00886333216215
• UDI-Public: (01)00886333216215(17)280428(10)11465767
• 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
• Report Date (Section B): 07/03/2024

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: 11465767
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 10/06/2023; 10/06/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/13/2023; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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