MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SCORPIONX PORTAL VEIN ACCESS SET; SCORPION PORTAL VEIN ACCESS SET

Model Number	TPS006
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
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
During tips procedure multiple passes were made towards the portal system and the needle kept deflecting further then anticipated.During inspection of the device it seems the needle bend additionally during the passes made.Visually the needle looked bent at the point between nitinol and stainless steel.The system was used as designed per ifu.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of returned product from the customer was performed.Visual inspection of the device did not identify any damage to the device.Since the product complaint mode could not be duplicated during evaluation, the complaint was not confirmed and no further evaluation is needed at this time.If additional information is available in future, a follow-up report will be submitted accordingly.
Event or Problem Description
During tips procedure multiple passes were made towards the portal system and the needle kept deflecting further then anticipated.During inspection of the device it seems the needle bend additionally during the passes made.Visually the needle looked bent at the point between nitinol and stainless steel.The system was used as designed per ifu.
Event or Problem Description
During tips procedure multiple passes were made towards the portal system and the needle kept deflecting further then anticipated.During inspection of the device it seems the needle bend additionally during the passes made.Visually the needle looked bent at the point between nitinol and stainless steel.The system was used as designed per ifu.
Additional Manufacturer Narrative
The sample is indicated as returned and is pending investigation.A follow-up report will be submitted once the sample has been investigated.

• Brand Name: SCORPIONX PORTAL VEIN ACCESS SET
• Common Device Name: SCORPION PORTAL VEIN ACCESS SET
• 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: 15365184
• Report Number: 0001625425-2022-01082
• Device Sequence Number: 6927575
• Product Code: DYB
• UDI-Device Identifier: 00886333225729
• UDI-Public: 00886333225729
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213002
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2022

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: 10/14/2024
• Device Model Number: TPS006
• Device Catalogue Number: TPS006
• Device Lot Number: 11388808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 08/25/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/12/2022; 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown