MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TRAVELER 21

Model Number	TPS002
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has been returned for evaluation.A follow-up report will be submitted once the investigation has been completed.
Event or Problem Description
The 10f sheath could not be advanced into the dilated liver parenchyma over a 0.035¿ boston scientific super stiff amplatz wire.The dr.Tried to reinsert the 10f introducer (blue argon), but it would not advance into the sheath.A cook 10f introducer (grey, sti ll in sheath for return & in pics) was then inserted but would not be advanced beyond a certain point into the sheath.The entire sheath had to be exchanged and removed for another new sheath.The patient experienced an intraperitoneal hemorrhage after the exchange of the sheath in the dilated parenchyma where the sheath was supposed to be advanced.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text: placeholder.

• Brand Name: TRAVELER 21
• Common Device Name: TRAVELER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11572437
• Report Number: 1625425-2021-00882
• Device Sequence Number: 4010051
• Product Code: DYB
• UDI-Device Identifier: 00886333224630
• UDI-Public: 00886333224630
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2021

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: 08/09/2021
• Device Model Number: TPS002
• Device Catalogue Number: TPS002
• Device Lot Number: 11353364
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/15/2021; 05/11/2021
• 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