MAUDE Adverse Event Report: IMPERATIVE CARE INC. SYMPHONY CATHETER

Model Number	SYMPHONY24F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/07/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The symphony 24f device was discarded and not returned for investigation.The manufacturing records were reviewed and showed the product met design and manufacturing specifications.Based on the information provided, the cause of the adverse event could not be conclusively determined.There was no malfunction or device issue reported with the symphony 24f during the procedure.
Event or Problem Description
It was reported that during a pulmonary embolism (pe) procedure, the symphony 24f was advanced through the heart to the left pulmonary artery and after the first pass of 6 pulses, the patient began to cough up blood.The device was removed, and the thrombectomy procedure was aborted.Despite resuscitative efforts, the patient expired due to hypovolemia.A perforation of the left main pulmonary artery was identified after the patient had coded.The cause of the perforation could not be definitively determined and may have been related to trauma associated with multiple rounds of cardiopulmonary resuscitation (cpr)or potentially catheter-related trauma.It was indicated that coiling of the pulmonary artery (pa) was attempted after the patient coded; however, the patient expired before the coiling procedure could be completed.At this time, it remains unclear whether the device contributed to the adverse event.The physician stated the clinical outcome would have been the same regardless of device use.

• Brand Name: SYMPHONY CATHETER
• Common Device Name: SYMPHONY CATHETER
• Manufacturer (Section D): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer Contact: katharine treangen ; 1359 dell ave; campbell, CA 95008-6609 ; 4082029060
• MDR Report Key: 25353603
• Report Number: 3014590708-2026-00020
• Device Sequence Number: 10302271
• Product Code: QEW
• UDI-Device Identifier: 00850032079129
• UDI-Public: (01)00850032079129(17)261111(10)V2527909
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K252057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: SYMPHONY24F
• Device Catalogue Number: SYMPHONY24F
• Device Lot Number: V2527909
• 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: 05/07/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2025
• 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: AMPLATZ SUPER STIFF; GORE DRYSEAL; THIRD PARTY COILS
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American