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

Model Number	ICRC035158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A 56-year-old female patient was treated for an occlusion in the left proximal m2 segment.Access was obtained using a zoom 88 access catheter to the internal carotid artery (ica).During the first pass, a zoom 55 aspiration catheter and a guidewire were advanced to the face of the clot in the left middle cerebral artery.The guidewire was then advanced pass the occlusion.Zoom 55 could not be advanced through the clot.Aspiration was applied to the zoom 55 for approximately 1-2 minutes, but the clot was not removed.After a contrast run, imaging showed no change in the occlusion at the proximal m2 segment.There was no indication of extravasation.For the second pass, the zoom 88 remained parked in the ica as the same zoom 55 was advanced over a zoom 35 aspiration catheter and the guidewire.The guidewire was again advanced into the m2 segment.The zoom 35 would not pass the occlusion but sat at the opening of the m2 segment.The physician then advanced the zoom 55 into the m1 segment to provide support to the zoom 35.While advancing the zoom 35 , (as the zoom 55 remained stationary) the zoom 35 and guidewire prolapsed into the m1 segment.The zoom 35 and guidewire were retracted into the zoom 55.The physician attempted to advance the guidewire into the occluded m2 segment but noticed that the guidewire took a different trajectory.The patient was noted to be hemodynamically stable with no changes.When the guidewire took a different trajectory, the physician injected a puff of contrast through the zoom 88 and noticed a slight sign of extravasation.The zoom 35, zoom 55 and guidewire were then removed from the patient.The zoom 88 was advanced to the terminus of the ica.A balloon was advanced through the zoom 88 into the m1 segment to provide tamponade.Contrast runs showed an active extravasation at the distal m1 segment.The m1 segment was successfully embolized with coils.After the balloon was deflated, all devices were removed from the patient.Imaging showed a flow into the a1 with minimal extravasation from collaterals.The procedure was aborted, and an external ventricular drainage (evd) was placed.Computed tomography (ct) scan showed subarachnoid hemorrhage (sah) with some filling of the fourth ventricle.The patient was transferred to the icu.There was no device deficiencies reported with the zoom devices.
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 35 or zoom 55.Based on case images and information provided, a guidewire, zoom 55, and zoom 35 were in the location of the m1 segment.It is unclear if the extravasation and sah were caused by the zoom 55, zoom 35 or the guidewire.The manufacturing records for the zoom devices were reviewed and demonstrated that the product met all the design and manufacturing specifications.The following mfr # are submitted: mfr # 3014590708-2024-00036 for zoom 35.Mfr # 3014590708-2024-00037 for zoom 55.

• 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: 20626555
• Report Number: 3014590708-2024-00036
• Device Sequence Number: 15672030
• Product Code: NRY
• UDI-Device Identifier: 00812212030443
• UDI-Public: 00812212030443
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/06/2024

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 Expiration Date: 01/29/2026
• Device Model Number: ICRC035158
• Device Catalogue Number: ICRC035158
• Device Lot Number: F2331803
• 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: 10/08/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• 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 GUIDEWIRE.; COILS.; SCEPTER XC BALLOON.; ZOOM 55.; ZOOM 88.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 50 KG