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	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a neurovascular procedure the physician accessed the mma with a plato 17 (pl17-160-000) through a penumbra 5f ber catheter.The physician did a micro injection and when they looked down the hub of the plato 17 had broken off.The broken device was removed and another plato 17 was used to finish the case.The patient was not harmed as a result of the 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.Further follow-up with the sales representative on 21-jan-2026 confirmed that the doctor held the syringe to inject with one hand while supporting the catheter with the other hand.The break may have been as a result of how the doctor was handling the device and the syringe while doing the injection then subsequently breaking, however, this cannot be confirmed.

• 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: 24407816
• Report Number: 3009546466-2026-00037
• Device Sequence Number: 10113519
• Product Code: QJP
• UDI-Device Identifier: 00818075010455
• UDI-Public: 00818075010455
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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 Model Number: 01121
• Device Catalogue Number: PL17-160-000
• Device Lot Number: 043828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2026
• 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 5F BER CATHETER.
• Patient Sex: Unknown