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

Model Number	TPS005
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Peek catheter was advanced toward the portal vein.The stylet was removed to attempt to aspirate portal blood.Stylet was placed back into the catheter to attempt another ¿pass¿.Distal 3 inches of the peek catheter was observed, under fluoro, to be detached in the hepatic vein (see picture).Peek catheter segment was retrieved with a triple loop snare from the hepatic vein.
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
Peek catheter was advanced toward the portal vein.The stylet was removed to attempt to aspirate portal blood.Stylet was placed back into the catheter to attempt another ¿pass¿.Distal 3 inches of the peek catheter was observed, under fluoro, to be detached in the hepatic vein (see picture).Peek catheter segment was retrieved with a triple loop snare from the hepatic vein.
Additional Manufacturer Narrative
Sample is indicated as returned.As of the date of this report, sample has not been investigated.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 and non-conformances were recorded.A review of the returned product from the customer was performed visually.Visual inspection of the sample returned from the customer found scorpion cannula sheath was broken from the distal side of the cannula sheath, scorpion needle stiffener handle was bent and unable to be removed from the needle sheath.Hence the complaint was confirmed.Customer provided the internal body image.Vp of medical affairs reviewed the image and stated the following "based on the description given as well as the condition of the device with regards to the handle it would seem that when the customer placed the needle stylet back into the catheter the peek catheter may have had a slight bend in it and instead of the needle transitioning all the way through the catheter, the needle stylet may have been pushed out the side wall of the catheter which resulted in the catheter cracking and being left behind when the system was remove from the portal vein and withdrawn back into the hepatic vein.It is hard to completely say that this was the issue with 100% certainty but based on the description given as well as the imaging i believe this may have been the causative mechanism.Questions to ask the account maybe if they felt resistance when introducing the stylet back into the catheter, that resistance may have been the tip of the needle stylet pushing up against the wall of the catheter".No corrective action is required at this time because a manufacturing defect could not be confirmed.
Event or Problem Description
Peek catheter was advanced toward the portal vein.The stylet was removed to attempt to aspirate portal blood.Stylet was placed back into the catheter to attempt another ¿pass¿.Distal 3 inches of the peek catheter was observed, under fluoro, to be detached in the hepatic vein (see picture).Peek catheter segment was retrieved with a triple loop snare from the hepatic vein.

• Brand Name: SCORPION 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: 16458137
• Report Number: 0001625425-2023-00980
• Device Sequence Number: 2393672
• Product Code: DYB
• UDI-Device Identifier: 00886333225552
• UDI-Public: 00886333225552
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2023

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: 10/30/2024
• Device Model Number: TPS005
• Device Catalogue Number: TPS005
• Device Lot Number: 11392840
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 02/15/2023; 02/15/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/30/2023; 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown