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	Embolism/Embolus (4438)
Date of Event	12/09/2025
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 physician identified a hypercoagulable state as the primary contributing factor to the adverse outcome.There was no malfunction or device issue noted with the symphony 24f during the procedure.
Event or Problem Description
It was reported that during a pulmonary embolism (pe) thrombectomy procedure, the physician navigated a pigtail catheter to main pulmonary artery (pa) and performed power injection confirming the clot location to be bilateral.Third party devices were used and symphony 24f was advanced to the right pulmonary artery (pa).One pass was performed with the symphony 24f catheter which retrieved significant clot.At this point, the patient began coughing, however no hemoptysis was noted.The symphony 24f was repositioned to main pulmonary artery (pa), and the patient began to decompensate.The physician reinserted the dilator, advanced third-party wire, and used symphony 24f to the ostium of lateral branch.A pass was performed however no clot was retrieved.Symphony 16f was then used and the patient continued to decompensate.Chest compressions were initiated.The physician then used symphony 16f, but no clot was retrieved.Thrombectomy procedure was stopped, and a code was called.Power injection was performed while the staff continued with chest compressions.A large clot was noted in the right pulmonary artery.The physician used symphony 24f to the right side as chest compressions continued.Sluggish flow was noted on power injection; however, no clot was removed from the second pass on the right.Extracorporeal membrane oxygenation (ecmo) preparation was started but after ~30 minutes of resuscitation, the patient had no pupillary response and was pronounced deceased.The physician indicated that the patient's cardiac arrest and subsequent death were not attributed to the symphony device or the thrombectomy procedure.The patient had experienced symptoms similar to those present at the time of decompensation prior to the procedure.The physician identified a hypercoagulable state as the primary contributing factor to the adverse outcome.

• 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
• MDR Report Key: 23986563
• Report Number: 3014590708-2026-00001
• Device Sequence Number: 17300730
• Product Code: QEW
• UDI-Device Identifier: 00850032079129
• UDI-Public: (01)00850032079129(17)261111(10)V2527909
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/06/2026

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: 12/09/2025
• Initial Report FDA Received Date: 01/06/2026
• 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: 24F GORE DRYSEAL 33CM SHEATH; 6F SHEATH; AMPLATZ WIRE; GLIDEWIRE ADVANTAGE; MICROPUNCTURE KIT; PIGTAIL CATHETER; POWER INJECTION; SYMPHONY 16F; VERTEBRAL CATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 43 YR
• Patient Sex: Female