MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SCORPIONX PORTAL VEIN ACCESS SET; INTRODUCER, CATHETER

Model Number	TPS006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, the scorpion x set was used as transjugular access to the portal vein.When manipulating the peek catheter together with the puncture needle (17 g), the peek component fractured (broke), leaving a segment of it retained inside the patient (approximately 3.5 cm).The breakage occurred during the first puncture attempt; the distal tip of the peek catheter broke immediately.Subsequently, an attempt was made to recover the component endovascularly, but this was unsuccessful.The material remains in the patient.Currently, the segment that remained inside the patient migrated to a hepatopulmonary shunt.
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.

• Brand Name: SCORPIONX PORTAL VEIN ACCESS SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 76008 ; 9036759321
• MDR Report Key: 23359497
• Report Number: 0001625425-2025-01106
• Device Sequence Number: 15726147
• Product Code: DYB
• UDI-Device Identifier: 00886333225729
• UDI-Public: (01)00886333225729(17)280626(10)11628102
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TPS006
• Device Lot Number: 11628102
• Was Device Available for Evaluation?: Yes
• 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: 09/23/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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: Required Intervention
• Patient Sex: Unknown