MAUDE Adverse Event Report: ARGON MEDICAL DEVICES POINTER NITINOL GUIDEWIRE 0.018" (0.46MM) X 300CM SOFT TIP 40MM

Model Number	180418300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A doctor reported that during manual configuration of the wire tip by the user, part of the wire wound as a coil became detached at the tip of the pointer wire and was drawn out in length.The pointer wire can therefore no longer be used for the procedure.Additional information received from the doctor stating the patient was not at risk at any point during the procedure, as the pointer wire did not come into direct contact with the patient.The patient had pad and the aim of the treatment was to probe and dilate the artery superficialis and popliteal artery poplitea with a balloon catheter (pta).When configuring the pointer wire for better and faster probing of the target vessel by the treating physician with his fingers, the micro wire wound as a coil came loose at the tip of the pointer wire and was stretched out lengthwise.The pointer wire was immediately removed from the sterile table and immediately carried out of the angiography for later return to argon medical devices.The procedure was successful with other products from the competition without any restrictions for the patient.
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.One used sample was returned to argon from the customer for review.A visual inspection was performed on the returned sample.The visual inspection determined that the core was separated from the coil and the coil was stretched out and damaged.The damage suggests that the guidewire has gotten stuck and was pulled using excessive force to retrieve it.It is currently not known if the cause of the issue is due to insufficient gluing/curing, or if it is a result of an event within the user's environment.Since a root cause cannot be determined at this time, no further action can be taken.However, argon will continue to monitor for recurrence.Additional information provided in h.3., h.6.And h.11.

• Brand Name: POINTER NITINOL GUIDEWIRE 0.018" (0.46MM) X 300CM SOFT TIP 40MM
• Common Device Name: POINTER NITINOL GUIDEWIRE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens 75751 ; 9036759321
• MDR Report Key: 20260518
• Report Number: 0001625425-2024-01110
• Device Sequence Number: 12616198
• Product Code: DQX
• UDI-Device Identifier: 00886333000753
• UDI-Public: (01)00886333000753(17)261018(10)11389271
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 180418300
• Device Lot Number: 11389271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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