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

Model Number	ICTC088110
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A zoom 88 was returned with a third-party stent retriever system within its lumen.Device investigation confirmed shaft breakage and suggested that axial force was applied during the procedure, resulting in separation of the distal segment.The manufacturing records for the zoom 88 were reviewed and confirmed that the product met all applicable design and manufacturing specifications.The exact root cause could not be determined based on the device investigation and the limited case details available.Per follow-up information provided by the customer, the patient presented with tortuous anatomy, and a type iii aortic arch was identified as a potential contributing factors to the reported event.
Event or Problem Description
It was reported that the patient underwent a mechanical thrombectomy of the m1 segment utilizing zoom 88, third party guidewire and sheath.The patient's anatomy was tortuous.A total of three passes were completed, resulting in successful clot removal.Following physical inspection of the returned device, the distal portion of zoom 88 was found to be fractured.The patient's post procedure status is unknown.

• 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: 24584305
• Report Number: 3014590708-2026-00008
• Device Sequence Number: 18422240
• Product Code: NRY
• UDI-Device Identifier: 00812212030368
• UDI-Public: (01)00812212030368(17)280723(10)F2520301
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/12/2026

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: ICTC088110
• Device Catalogue Number: ICTC088110
• Device Lot Number: F2520301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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 24 GUIDEWIRE; CORDIS STENT SYSTEM; SHORT 8F SHEATH; ZOOM SUPPORT
• Patient Age: 64 YR
• Patient Sex: Male