MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM CATHETER

Model Number	ICRC055137
Medical Device Problem Codes	Break (1069); Material Separation (1562); Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a thrombectomy procedure targeting a clot located at the internal carotid artery (ica) terminus and subsequently the distal m1 or proximal m2, femoral access was obtained using a zoom support device.Tight stenosis and an s-turn within the vertebral artery resulted in the zoom 88 being positioned within the subclavian artery.The zoom 55 was unable to advance through the stenosis around the s-turn.After three attempted passes with the zoom 55, a zoom 35 was loaded into the zoom 55 on the back table outside the patient.Resistance was encountered while loading zoom 35 into the zoom 55 catheter and upon withdrawal of zoom 35, the zoom 55 accordioned and was observed to separate within the mid-shaft outside the body.The broken piece was outside the patient and no intervention was needed.The physician used a third-party device and switched to radial access for successful completion of the procedure.It was reported that there was severe vessel tortuosity, including stenosis at the takeoff of the left vertebral artery with an s-shaped configuration.Following the procedure, the patient experienced a subdural hemorrhage reportedly due to administration of tissue plasminogen activator (tpa).The physician indicated that the subdural hemorrhage was not related to the zoom devices or the thrombectomy procedure.The patient's current status is unknown.
Additional Manufacturer Narrative
A zoom 55 was returned for investigation.Investigation confirmed shaft separation of the zoom 55 catheter.The zoom 55 was returned separated into distal and proximal catheter segments.Device investigation identified damage to the catheter shaft consistent with an axial force being applied during the procedure, resulting in stretching of shaft materials prior to the zoom 55 catheter breaking.The reported complaint indicated that the zoom 35 was advanced into the zoom 55 while on the back table outside of the patient and resistance was noted.Upon retraction of the zoom 35 from the zoom 55, shaft separation of the zoom 55 was observed.The instructions for use (ifu) includes precautions, "prior to use, ensure that the dimensions (e.G., diameter and length) of the catheters and accessory/adjunctive devices to be used in the procedure are compatible with each other and appropriate for the target vasculature".The manufacturing records for zoom 55 were reviewed and confirmed the product met all the design and manufacturing specifications prior to release.

• 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: 25307948
• Report Number: 3014590708-2026-00019
• Device Sequence Number: 18607115
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: (01)00812212030474(17)280912(10)F2525402
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2525402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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: EV3 REBAR 18 MICROCATHETER.; RHV CO-PILOT.; SYNCHRO SELECT .014.; TERUMO GLIDEWIRE .035".; ZOOM 35.; ZOOM SUPPORT.
• Patient Age: 71 YR
• Patient Sex: Female