MAUDE Adverse Event Report: ARGON MEDICAL DEVICES WORKER GUIDEWIRE - STANDARD STRAIGHT 0.035"/0.89MM X 80CM - 3.5CM

Model Number	110135080
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Worker guidewire the tip of the wire is not in the start position, it is the back of the wire that is in the purple connector.The customer have been aware of this, after they have seen several cases of that.
Additional Manufacturer Narrative
Sample is not available for return.Argon is investigating this event and 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.There was no photographic or physical evidence returned by the customer that would have allowed an investigation to take place.However, the complaint is regarding a confirmed issue produced within the same lot number.The guidewires are loaded by hand in the dispensers prior to the tray forming process.The incorrect guidewire orientation was not detected during packaging or final inspections before boxing.Because the root cause was found to be operator related, the area supervisor was made aware of the issue and retraining was provided to the operators.Argon will continue to monitor for recurrence.
Event or Problem Description
Worker guidewire the tip of the wire is not in the start position, it is the back of the wire that is in the purple connector.The customer have been aware of this, after they have seen several cases of that.
Additional Manufacturer Narrative
Corrected information provided in d4 and g4 due to an error in the previous mdr.

• Brand Name: WORKER GUIDEWIRE - STANDARD STRAIGHT 0.035"/0.89MM X 80CM - 3.5CM
• Common Device Name: WORKER 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: 17913283
• Report Number: 0001625425-2023-01219
• Device Sequence Number: 7472645
• Product Code: DQX
• UDI-Device Identifier: 00886333007912
• UDI-Public: (01)00886333007912(17)280608(10)11482420
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160785
• 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): 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: 110135080
• Device Lot Number: 11482420
• Was Device Available for Evaluation?: No
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 10/04/2023; 06/13/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/20/2023; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• 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