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

Model Number	TPS005
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.A follow-up report will be submitted once the investigation has been completed.
Event or Problem Description
Two foreign bodies were noticed on post stent deployment imaging.A foreign body was noticed in the heart and jailed between the stent and body.The tip of the 10f sheath did not look intact on imaging.When the sheath was removed, a the distal end was not whole and a section fragmented.
Event or Problem Description
Two foreign bodies were noticed on post stent deployment imaging.A foreign body was noticed in the heart and jailed between the stent and body.The tip of the 10f sheath did not look intact on imaging.When the sheath was removed, a the distal end was not whole and a section fragmented.
Additional Manufacturer Narrative
One opened 10f introducer sheath was returned for evaluation.Visual inspection of the sheath established that the tip was cracked, and a piece was missing, thereby confirming the complaint.The sheath¿s original blunt end design was changed to a new dual-taper tip design to improve the ease of passing the tip through the parenchyma.The od and the id of the tube were increased by 0.003¿, and the tip geometry was changed from a single radius blunt tip to a dual-taper sharp tip that resulted in a thinner wall thickness at the most distal tip of the catheter.The potential root cause for the sheath tip failure has not yet been conclusively determined.It is theorized that it might be the result of the material used, processing parameters of the material, and/or the new tip geometry.Capa c-2021-046 has been initiated to capture the root cause investigation.No product currently exists in the field while this investigation is being conducted.

• Brand Name: SCORPION PORTAL VEIN ACCESS SET
• Common Device Name: SCORPION
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12207099
• Report Number: 0001625425-2021-01040
• Device Sequence Number: 3970819
• Product Code: DYB
• UDI-Device Identifier: 00886333225552
• UDI-Public: 00886333225552
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K202141
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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 Expiration Date: 05/21/2023
• Device Model Number: TPS005
• Device Catalogue Number: TPS005
• Device Lot Number: 11369609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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