MAUDE Adverse Event Report: SCIENTIA VASCULAR SOCRATES; CATHETER

Model Number	01751
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From review of the manufacturing lot history record, there is no indication that the break occurred due to a manufacturing defect, and it confirms the lot met the relasing criteria.
Event or Problem Description
During an intracranial coiling of a pericalloasal hemorrhage aneurysm a socrates 038 catheter fractured and became displaced / separated while inside of a zebra guide catheter.The physician noted the zebra catheter was kinked but also noted the procedure was completed with a benchmark catheter through the same zebra catheter without inicident and there was no injury to the patient.The physician noted toruous anatomy and an acute turn going from the a1 to the a2 branch.The displaced piece of the socrates 038 catheter was removed using aspiration before continuing the procedure using the benchmark.
Event or Problem Description
During an intracranial coiling of a pericallosal hemorrhage aneurysm a socrates 038 catheter fractured and became displaced/separated while inside of a zebra guide catheter.The physician noted the zebra catheter was kinked but also noted the procedure was completed with a benchmark catheter through the same zebra catheter without incident and there was no injury to the patient.The physician noted tortuous anatomy and an acute turn going from the a1 to the a2 branch.The displaced piece of the socrates 038 catheter was removed from the zebra catheter using aspiration before continuing the procedure using the benchmark.

• 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: 23903168
• Report Number: 3009546466-2025-00020
• Device Sequence Number: 20091121
• Product Code: QJP
• UDI-Device Identifier: 00818075011025
• UDI-Public: 00818075011025
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K242301
• 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): 12/26/2025

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: 07/31/2026
• Device Model Number: 01751
• Device Catalogue Number: SC038-127-001
• Device Lot Number: 038900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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: Q'APEL MEDICAL ZEBRA GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown