MAUDE Adverse Event Report: ARGON MEDICAL DEVICES AMC/3 ARTERIAL NEEDLE 21GA X 1

Model Number	195311
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of nitrex guidewire sheared off and was retained extravascularly while attempting left femoral arterial access for diagnostic peds cardiac cath.Immediately contacted surgeon, and then peds surgery doctor.Determined it was safe to leave in place.Proceeded and completed case with no other issues.Doctor notified patient family at completion of case.Specific item: ev3 nitrex.018" x 80 cm guidewire.Ref# n180801, lot# 6675783.Used in conjunction with argon medical devices amc/3 arterial needle 21ga x 1" ref# 195311.What was the original intended procedure? : left femoral arterial access for diagnostic peds cardiac cath.
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.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.Per argon ifu9012, "the guidewire should not be withdrawn through the needle.Damage or shearing of guidewire may occur." after three notifications, the sample from the alleged complaint has not returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without a device to evaluate, determining root cause or corrective action is not possible.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
Event or Problem Description
Tip of nitrex guidewire sheared off and was retained extravascularly while attempting left femoral arterial access for diagnostic peds cardiac cath.Immediately contacted surgeon, and then peds surgery doctor.Determined it was safe to leave in place.Proceeded and completed case with no other issues.Doctor notified patient family at completion of case.Specific item: ev3 nitrex.018" x 80 cm guidewire.Ref#: (b)(4), lot#: 6675783.Used in conjunction with argon medical devices amc/3 arterial needle 21ga x 1" ref#: (b)(4).What was the original intended procedure? left femoral arterial access for diagnostic peds cardiac cath.

• Brand Name: AMC/3 ARTERIAL NEEDLE 21GA X 1
• Common Device Name: ARTERIAL NEEDLE
• 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: 17305462
• Report Number: 0001625425-2023-01113
• Device Sequence Number: 7120446
• Product Code: GDF
• UDI-Device Identifier: 00886333208371
• UDI-Public: 00886333208371
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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 Expiration Date: 07/23/2026
• Device Model Number: 195311
• Device Catalogue Number: 195311
• Device Lot Number: 11374158
• Was Device Available for Evaluation?: No
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2021
• 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; Required Intervention
• Patient Sex: Unknown