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

Model Number	TPS006
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the sample will get returned for evaluation or not.A follow-up report will be submitted once more information becomes available.
Event or Problem Description
Broke in the sheath while in the patient.
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.
Event or Problem Description
Broke in the sheath while in the patient.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.R&d engineer, quality engineer and complaint analyst reviewed the sample.Sample was inspected visually and it was found that sheath and needle were broken from distal side (curve start on the needle).Functional evaluation of the device found excess force was applied during the advancement and device was twisted at the same time to cause the needle to break which confirmed the complaint.The exact root cause was not determined, but possible root cause of this issue could be user error.During the procedure when user advanced the device, the device probably came across hard tissue, and applying excess force along with twisting the device, caused it to bend and break.Since the breakage was related to an event within the user environment, no corrective action is required at this time.
Event or Problem Description
Broke in the sheath while in the patient.

• 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: 15266753
• Report Number: 0001625425-2022-01077
• Device Sequence Number: 12238809
• Product Code: DYB
• UDI-Device Identifier: 00886333225729
• UDI-Public: 00886333225729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Other
• 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
• Device Expiration Date: 10/20/2024
• Device Model Number: TPS006
• Device Catalogue Number: TPS006
• Device Lot Number: 11388809
• Was Device Available for Evaluation?: Yes
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 08/03/2022; 08/03/2022
• Initial Report FDA Received Date: 08/22/2022
• 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