MAUDE Adverse Event Report: SCIENTIA VASCULAR SOCRATES; CATHETER

Model Number	01370
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a neurovascular procedure the physician was using a socrates 038 catheter in conjunction with a red 72 catheter as well as an aristotle colossus wire.The socrates catheter and colossus wire tracked nicely and got where it was needed, however, when the physician tried to advance the red 72 catheter it would not go.The physician then applied suction using the socrates but the clot was too large.The physician tried to remove the socrates catheter but it got stuck and broke at the distal 1/3 of the catheter.The physician was able to get the catheter piece out by applying suction using the red 72 catheter.The physician also noted a lot of tortuosities in the vessel and a stenosis in the common carotid artery.There was no harm to the patient as a result of the malfunction and the procedure was subsequently completed with other products.
Additional Manufacturer Narrative
A review of the manufacturing lot was conducted and all tests and inspections met the acceptance criteria for lot release.Confirmation with the sales representative in email on 06nov2025 revealed that the proximal portion of the catheter had been discarded.

• Brand Name: SOCRATES
• Common Device Name: CATHETER
• Manufacturer (Section D): SCIENTIA VASCULAR; 2460 south 3270 west; west valley city UT 84119
• Manufacturer (Section G): SCIENTIA VASCULAR; 2460 south 3270 west; west valley city UT 84119
• Manufacturer Contact: joshua verlac ; 2460 south 3270 west; west valley city, UT 84119
• MDR Report Key: 23663103
• Report Number: 3009546466-2025-00017
• Device Sequence Number: 8910167
• Product Code: NRY
• UDI-Device Identifier: 00818075010776
• UDI-Public: 00818075010776
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K223913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 01370
• Device Catalogue Number: SC038-156-001
• Device Lot Number: 033459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PENUMBRA RED 72 REPERFUSION CATHETER; SCIENTIA VASCULAR ARISTOTLE COLOSSUS GUIDEWIRE
• Patient Sex: Unknown