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	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a venous sinus stenting procedure the physician used a zoom 88 to navigate to the transverse sinus.There was presence of stenosis and/or calcification.Zoom 88 successfully crossed the lesion, and a third-party stent was deployed.Upon removal of zoom 88 from the patient, the physician noticed that the distal 5 cm of the device was broken.There were no fragments left in the patient.
Additional Manufacturer Narrative
The zoom 88 device was discarded and not returned for investigation.The manufacturing records were reviewed and showed the product met design and manufacturing specifications.Without the return of the device, the exact root cause for the shaft break could not be determined.

• 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: 24076100
• Report Number: 3014590708-2026-00002
• Device Sequence Number: 15799592
• Product Code: NRY
• UDI-Device Identifier: 00812212030368
• UDI-Public: (01)00812212030368(17)280130(10)F2502901
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/14/2026

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: F2502901
• 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: 12/16/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .035 GLIDEWIRE; 125 CM GLIDECATH; COOK G52543 CXI SUPPORT CATHETER 4.0FR, .035" X 13; COOK SHUTTLE; ZILVER 8X80 STENT
• Patient Sex: Unknown