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	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a neurovasular stroke case the physician was using a red 62 reperfusion catheter in conjunction with a socrates 38 aspiration catheter and a aristotle colossus guidewire.During the case the physician was able to advance the socrates 38 and colossus guidewire beyond the ophthalmic, but unable to advance the large bore catheter.The physician subsequently attemped to remove the catheter.During the removal of the socrates 38 catheter from the system the physician felt resistance upon which the socrates catheter broke.
Event or Problem Description
During a neurovasular stroke case the physician was using an imperative care zoom 71 aspiration catheter and a red 62 reperfusion catheter in conjunction with a socrates 38 aspiration catheter and a aristotle colossus guidewire.During the case the physician was using the zoom 71 with the socrates 38 and colossus guidewire, but the zoom 71 would not advance over the socrates 38 catheter.The physician then switched to the red 62 and was able to advance the socrates 38 and colossus guidewire beyond the ophthalmic, but unable to advance the large bore catheter.The physician subsequently attemped to remove the socrates 38 catheter.During the removal of the socrates 38 catheter from the system the physician felt drag upon which the socrates catheter was damaged.

• 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: 23086471
• Report Number: 3009546466-2025-00012
• Device Sequence Number: 9702340
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 12/31/2025
• Device Model Number: 01370
• Device Catalogue Number: SC038-156-001
• Device Lot Number: 037203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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: ARISTOTLE COLOSSUS GUIDEWIRE.; IMPERATIVE CARE ZOOM 71 ASPIRATION CATHETER.; PENUMBRA RED 62 REPERFUSION CATHETER.
• Patient Sex: Unknown