MAUDE Adverse Event Report: CIRCA SCIENTIFIC, INC. PERICROSS EPICARDIAL ACCESS KIT; CATHETER INTRODUCER

Model Number	PC-1013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital did not report this event at the time it occurred,, there was no alleged product deficiency.
Event or Problem Description
There was a right ventricular perforation with the pericross obturator.Physician used an amplatzer vascular plug to close the perforation.Procedure proceeded successfully gaining pericardial access using the pericross device.Patient was fine.

• Brand Name: PERICROSS EPICARDIAL ACCESS KIT
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): CIRCA SCIENTIFIC, INC.; 14 inverness drive east; suite h-136; englewood CO 80112
• Manufacturer (Section G): CIRCA SCIENTIFIC, INC.; 14 inverness drive east; suite h-136; englewood CO 80112
• Manufacturer Contact: fred piazza ; 14 inverness drive east; suite h-136; englewood, CO 80112 ; 3039518767
• MDR Report Key: 24607285
• Report Number: 3009437315-2026-00001
• Device Sequence Number: 12985509
• Product Code: DYB
• UDI-Device Identifier: 10851498007395
• UDI-Public: 10851498007395
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K243954
• 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): 03/16/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PC-1013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown