MAUDE Adverse Event Report: IMPERATIVE CARE INC. SYMPHONY CATHETER

Model Number	SYMPHONY16F82
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thrombectomy procedure, access was obtained via a third-party micropuncture device, 16f sheath and guidewire in the left popliteal vein.The wire was advanced with assistance of a third-party diagnostic catheter, followed by use of symphony 16f 82cm catheter over the guidewire.The symphony 16f 82cm catheter successfully crossed from the iliac to the inferior vena cava (ivc) and aspiration was performed successfully.A residual venogram revealed calcification.The physician deployed a third-party balloon and subsequent venogram revealed a non-flow limiting dissection in the femoral vein.Intravascular ultrasound (ivus) was then utilized for measurements and identifying residual clots.A second pass was then performed with symphony 16f 82cm catheter before placement of stent and post-dilation.Venography showed two residual chronic plaques, and a third pass with symphony 16f 82cm catheter cleared the chronic clot from the common femoral vein.The cause of the dissection is unknown and could be associated with the third-party wire, symphony 16f 82cm catheter, or third-party balloon.Per the physician, likely the balloon angioplasty led to the dissection.There was no device issue or malfunction reported with the symphony 16f 82cm during the procedure.
Additional Manufacturer Narrative
The device was discarded and not returned for investigation.The manufacturing records were reviewed and demonstrated that the product met the design and manufacturing specifications.Based on the information provided, there was no malfunction reported during the case.It is unknown if the dissection was caused due to third party devices or the symphony 16f 82cm catheter.

• 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: 23662071
• Report Number: 3014590708-2025-00027
• Device Sequence Number: 16006526
• Product Code: QEW
• UDI-Device Identifier: 00850032079211
• UDI-Public: (01)00850032079211(17)260816(10)F2519201
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/26/2025

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 Expiration Date: 08/16/2026
• Device Model Number: SYMPHONY16F82
• Device Catalogue Number: SYMPHONY16F82
• Device Lot Number: F2519201
• 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: 10/28/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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: 2 ATLAS BALLOON.; ABRE VENOUS STENT.; BERENSTEIN CATHETER.; COOK SHEATH.; GLIDE ADVANTAGE WIRE.; IVUS CATHETER.; MICROPUNCTURE DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown