MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM CATHETER

Model Number	ICRC035158
Medical Device Problem Codes	Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient presented with an acute ischemic stroke involving a tandem occlusion, with the target clot located in the middle cerebral artery (mca).Access was obtained through the right femoral artery using a zoom support catheter which was introduced through a third-party sheath.During the procedure, resistance was encountered during advancement/retraction through the carotid artery.Imaging indicated that the access catheter as well as zoom 35 kinked due to extreme tortuous anatomy.The physician exchanged the zoom support access catheter for a third-party guide catheter.Upon removal, the zoom 35 catheter was found to have fractured, with separation occurring approximately 30 cm from the distal end.An attempt to retrieve the separated catheter segment using a snare was unsuccessful, and the distal catheter segment remained within the patient's vasculature.The procedure was subsequently concluded, as the earlier thrombectomy attempt using the zoom 35 catheter had been unsuccessful.It was further reported that the patient expired a couple of days following the procedure; however, the exact date of death was not known.Based on the information provided, the cause of death could not be conclusively determined.According to the treating physician, the patient was considered high risk, and the physician believed the patient's death was unrelated to the reported device event.
Additional Manufacturer Narrative
The zoom 35 was discarded and not returned for investigation.The manufacturing records confirmed the product met all the design and manufacturing specifications.Without the return of the device, the exact root cause for the shaft break could not be determined.However, based on the available information, likely factors which contributed to the reported complaint were tortuous anatomy and advancement/retraction of the zoom 35 against resistance.Zoom ifu provides the following warning related to retraction against resistance."exercise care when manipulating the device through tortuous anatomy.Do not advance or withdraw the catheters or accessory/adjunctive devices against resistance without careful assessment of the cause under fluoroscopy.If the cause cannot be determined, withdraw all devices as a single unit.Excessive manipulation or torquing the device against resistance may result in damage to the vasculature or the device.".

• 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: 25756162
• Report Number: 3014590708-2026-00026
• Device Sequence Number: 10532183
• Product Code: NRY
• UDI-Device Identifier: 00812212030443
• UDI-Public: (01)00812212030443(17)280519(10)F2513502
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICRC035158
• Device Catalogue Number: ICRC035158
• Device Lot Number: F2513502
• 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: 06/10/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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: ARISTOTLE 14 STD 200 CM (2); ARISTOTLE 14 STD 300 CM; DEV INFLATION DIGITAL BALLOON; GUIDEWIRE ANG 038 180 3 CM TIP; MICROCATH VELOCITY 164 CM; MICROCATHETER RENEGADE HI FLO 150; SHETH PIN 9F 10 CM; SNARE MICROKIT 2MM; STERLING BALLOON 5X30X135 150; VALVE BLEEDBACK COPILOT; ZEBRA 7F ACCESS CATHETER 95 CM; ZOOM 4S 125 CM; ZOOM 6F VRT 137 CM; ZOOM POD; ZOOM SUPPORT
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White