MAUDE Adverse Event Report: ARGON MEDICAL DEVICES HALO SINGLE LOOP SNARE KIT 6F, 15MM X 120CM

Model Number	383615120
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562); Separation Problem (4043)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
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
It was reported that dr.(b)(6) had snared a port and catheter, then tried to advance to port with the snare and the radiopaque marker band came off the catheter.It was retrieved and the entire unit is able to be sent back.
Event or Problem Description
It was reported that dr.Guan had snared a port and catheter, then tried to advance to port with the snare and the radiopaque marker band came off the catheter.It was retrieved and the entire unit is able to be sent back.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One used sample was sent to argon from the customer.A visual inspection was performed on the returned product.The visual inspection determined that the radiopaque band was not present on the catheter.Since this is the first complaint with this issue with this part and lot number, this will be treated as an isolated occurrence.
Event or Problem Description
It was reported that dr.(b)(6) had snared a port and catheter, then tried to advance to port with the snare and the radiopaque marker band came off the catheter.It was retrieved and the entire unit is able to be sent back.

• Brand Name: HALO SINGLE LOOP SNARE KIT 6F, 15MM X 120CM
• Common Device Name: HALO
• 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: 16530875
• Report Number: 0001625425-2023-00999
• Device Sequence Number: 7159738
• Product Code: MMX
• UDI-Device Identifier: 00886333224883
• UDI-Public: 00886333224883
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K200268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2023

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: 09/14/2025
• Device Model Number: 383615120
• Device Catalogue Number: 383615120
• Device Lot Number: 11438729
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 03/06/2023; 03/06/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/19/2023; 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown