MAUDE Adverse Event Report: SCIENTIA VASCULAR PLATO; CATHETER

Model Number	01121
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a neurovascular procedure, the doctor was using a pl17-160-000 catheter.The doctor was able to access the mma with the catheter and while in the process of doing an angiogram using a 3cc medallion syring and the catheter broke at the hub.The catheter was replaced with another product and the procedure was completed without incident or any harm to the patient.
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.Further follow-up with the sales representative on 23dec2025 confirmed that the doctor held the syringe using both hands when injecting to insure adequate filling of the vessel during injection.The break may have been as a result of how the doctor was handling the device and the syringe while doing the angiogram as well as possibly the weight of the syringe causing a kinking the catheter then subsequently breaking, however, this can not be confirmed and the cause of the device failure cannot be determined.

• Brand Name: PLATO
• 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: 23961152
• Report Number: 3009546466-2026-00001
• Device Sequence Number: 9528575
• Product Code: QJP
• UDI-Device Identifier: 00818075010455
• UDI-Public: 00818075010455
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K223560
• 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): 01/05/2025

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: 08/31/2026
• Device Model Number: 01121
• Device Catalogue Number: PL17-160-000
• Device Lot Number: 040919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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: MERIT MEDICAL 3CC MEDALLION SYRINGE; SCIENTIA VASCULAR ARISTOTLE 14 GUIDEWIRE
• Patient Sex: Unknown