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

Model Number TPS005

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The sample was returned for evaluation.A follow-up report will be submitted once the investigation has been completed.

Event 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 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.

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
• Type of Device: SCORPION
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12207099
• MDR Text Key: 264949241
• Report Number: 0001625425-2021-01040
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00886333225552
• UDI-Public: 00886333225552
• Combination Product (y/n): N
• PMA/PMN Number: K202141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other