MAUDE Adverse Event Report: IMPERATIVE CARE. INC ZOOM REPERFUSION CATHETER; CATHETER, THROMBUS RETRIEVER

Model Number	ICRC045144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Perforation of Vessels (2135)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A 66-year-old female patient was treated for an occlusion at the right m1 and m2 segment.Access was obtained using a zoom 88 access catheter to the internal carotid artery (ica).During the first pass, a zoom 71 aspiration catheter and a guidewire were advanced through the zoom 88 to the face of the clot in the right m1 segment.The guidewire was then removed, and aspiration was applied to the zoom 71.The right m1 segment was successfully recanalized.For the second pass, the zoom 88 was positioned in the petrous segment of the right ica.A zoom 45 aspiration catheter, a third-party microcatheter, and the guidewire were advanced through the zoom 88 to the right m2 segment occlusion.The physician reported "drastic" changes on the monitor, and soon after, extravasation was noted under fluoroscopy.At this time, the third-party microcatheter and the zoom 45 were in the right m2 segment, and the guidewire was just distal to the zoom 45.Another contrast run was performed and showed extravasation at the right m2 segment.Protamine was administered to stop the bleeding and the patient was intubated.Approximately five minutes later, the bleeding stopped.All devices were removed from the patient and the access site was closed.No device issues were reported.The patient remained intubated and sedated.No other patient sequelae were reported.
Additional Manufacturer Narrative
The devices were discarded after use and therefore not available for return and investigation.No device deficiencies were reported related to the zoom 45.Based on the information provided, the exact cause of the extravasation is unknown.The relationship with the zoom 45 device to the extravasation could not be established.It is unclear if the extravasation was caused by the zoom 45 device or other devices used in the case.The manufacturing records for the zoom 45 device were reviewed and demonstrated that the product met all design and manufacturing specifications.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE. INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE, INC.; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell; campbell, CA 95008-6609
• MDR Report Key: 20698500
• Report Number: 3014590708-2024-00038
• Device Sequence Number: 3714546
• Product Code: NRY
• UDI-Device Identifier: 00812212030498
• UDI-Public: 00812212030498
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K210996
• 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): 11/08/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: ICRC045144
• Device Catalogue Number: ICRC045144
• Device Lot Number: F2416402
• 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: 10/18/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2024
• 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: ARISTOTLE 24 GUIDEWIRE; MARKSMAN 160CM; ZOOM 88
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female