MAUDE Adverse Event Report: ARGON MEDICAL DEVICES WORKER GUIDEWIRE - 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
The wire has been loaded into the carrier the wrong way around, meaning the stiffer end is at the front- so is placed into the patient first rather than the soft 3.5cm tip end which is at the back.Update with per form.Worker guidewire.The hard/sharp end of the wire is in the start position of the product.So it is packed with the wrong end of wire in the start position.Because of back orders with this article the customer kept one box, and marked the box with warning! turn direction.Therefore only one box for inspection but credit 2 boxes.
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
The wire has been loaded into the carrier the wrong way around, meaning the stiffer end is at the front- so is placed into the patient first rather than the soft 3.5cm tip end which is at the back.Update with per form: worker guidewire.The hard/sharp end of the wire is in the start position of the product.So it is packed with the wrong end of wire in the start position.Because of back orders with this article the customer kept one box, and marked the box with warning! turn direction.Therefore only one box for inspection but credit 2 boxes.
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.Two samples, one sealed and one unsealed, were returned for review.Visual inspection of the devices revealed that the guidewires were loaded backwards in the dispensers.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.
Additional Manufacturer Narrative
Corrected information provided in d.4.And g.4.Due to an error in the previous mdr.

• Brand Name: WORKER GUIDEWIRE - 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: 17913232
• Report Number: 0001625425-2023-01218
• Device Sequence Number: 15327758
• 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?: 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: 10/01/2023
• Supplement Date Received by Manufacturer: 10/01/2023; 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): Yes
• 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