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

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoom 71 was not returned for investigation.The manufacturing records were reviewed and showed the product met 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 information provided, the internal carotid artery (ica), distal to the bifurcation was tortuous, which likely contributed to the resistance felt during attempted removal of the zoom 71 and the zoom 71 shaft break.
Event or Problem Description
It was reported that the patient underwent a mechanical thrombectomy of the left m1 segment.The internal carotid artery (ica) was noted to be highly tortuous distal to the bifurcation.Advancement of the zoom 88, zoom 71 and third-party stent retrieval was performed successfully.During the removal of zoom 71 and third-party stent retriever, significant resistance was felt, and the zoom 71 could not be withdrawn which resulted in removal of the third-party stent retriever, zoom 88 and the zoom 71 as a system.The zoom 71 was found to be fractured into two segments; however, all fragments were successfully retrieved.Following removal of the device, some extravasation was observed in the patient.The procedure could not be completed.

• 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: 24138975
• Report Number: 3014590708-2026-00003
• Device Sequence Number: 14816645
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: (01)00812212030450(17)271209(10)F2434102
• 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): 01/21/2026

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: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2434102
• 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: 12/22/2025
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2024
• 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: SOLITARE.; SYNCHRO WIRE.; VELOCITY.; ZOOM 88.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown