MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM CATHETER

Model Number	ICRC045144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoom 45 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, it is unclear if the dissection was caused by zoom 45, zoom 7x or third-party devices.There was no device issues reported for any of the zoom devices used during the case.As multiple devices were involved in the reported event, a related mdr was submitted for the same patient and incident under reference number 3014590708-2025-00032.
Event or Problem Description
It was reported that during a mechanical thrombectomy for an acute ischemic stroke involving the left m1/m2 arteries.The physician utilized a third-party medium carrier delivery catheter along with zoom 7x to access the clot located in the distal m1 segment of the left middle cerebral artery (mca).Zoom 7x was positioned in the distal m1 at the bifurcation of the superior & inferior branches.After the first pass with zoom 7x, the inferior division was patent, while the superior division remained occluded.The physician then advanced a zoom 45 into the superior branch but was unable to advance far enough, so deployed a third-party stent retriever across the occlusion, followed by zoom 45, and a second pass was performed.Some improvement was noted in the m2 superior branch; however, flow became stagnant in the inferior branch.At this point, a dissection was observed at the m1 bifurcation of the superior and inferior branches of the left mca, which the physician attributed as likely resulting from zoom 7x.The dissection became prominent as the procedure progressed; additional passes were attempted with a zoom 45 and a zoom 35 in the inferior branch resulting in temporary recanalization; however subsequent angiograms revealed recurrent stagnant flow.To address the dissection, the physician placed a stent, which initially restored flow but subsequently occluded due to insufficient radial force and/or thrombotic activity.Thrombogenic activity was noted proximal to the dissection site, and the physician suspected this contributed to inconsistent perfusion.An additional pass was performed with the zoom 7x in the mid/distal m1 segment to manage the newly formed thrombus.The outcome was tici 2a with no improvement from the initial presentation.The patient was stable post procedure and was discharged to neuro intensive care unit (icu).

• Brand Name: ZOOM CATHETER
• Common Device Name: ZOOM 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: 23857421
• Report Number: 3014590708-2025-00033
• Device Sequence Number: 10116496
• Product Code: NRY
• UDI-Device Identifier: 00812212030498
• UDI-Public: (01)00812212030498(17)270911(10)F2424102
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/19/2025

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: ICRC045144
• Device Catalogue Number: ICRC045144
• Device Lot Number: F2424102
• 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: 11/21/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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: BALT CARRIER DELIVERY CATHETER (MEDIUM); INFINITY PLUS GUIDE CATHETER (STRYKER); NEUROFORM ATLAS STENT (3X15); PHENOM MICROCATHETER; SOLITAIRE STENT RETRIEVER (4 MM); SYNCHRO GUIDEWIRE; ZOOM 35 CATHETER; ZOOM 7X CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American