MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM REPERFUSION CATHETER

Model Number	ICTC088110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoom 88 was discarded and not returned for investigation.The manufacturing records confirmed the product met the design, manufacturing, and quality specifications.Based on the information provided, the cause of the dissection enlargement is currently unknown.There was no allegation against the zoom 88 device and no device issues reported during the procedure.
Event or Problem Description
It was reported that a patient presented with a stroke and a small vessel dissection.The location of the dissection was high internal carotid artery (ica).During the procedure, the vessel became fully dissected while the zoom 88 and third-party wire were in the vessel.Multiple stents were placed for treatment.According to the physician, the zoom 88 did not cause the dissection.Additional information indicated that the patient already had a small dissection prior to the procedure, which enlarged during the case.It is unknown if the zoom 88 device caused or contributed to dissection enlargement.There was no device malfunction reported for the zoom 88, and the patient was stable post-procedure.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: ZOOM REPERFUSION 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: 23835118
• Report Number: 3014590708-2025-00030
• Device Sequence Number: 5067890
• Product Code: NRY
• UDI-Device Identifier: 00812212030368
• UDI-Public: (01)00812212030368(17)280331(10)F2508701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K242672
• 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): 12/17/2025

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 Model Number: ICTC088110
• Device Catalogue Number: ICTC088110
• Device Lot Number: F2508701
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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: CAROTID WALL STENT.; COLOSSUS 35.; ECLIPSE BALLOON.; EMBOTRAP.; SURPASS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male