MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM ¿ 88 LARGE DISTAL PLATFORM; GUIDE CATHETER

Model Number	ICTC088110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoom 88 catheter shaft was cut post procedure.The distal portion of the catheter was returned for investigation and the proximal portion was discarded.The distal end of the zoom 88 had a deformed marker band, and the opening of the distal tip was ovalized.Based on the complaint information provided and device investigation, the root cause for the "vessel dissection" could not be determined.The manufacturing records were reviewed and demonstrated that the product met all the design and manufacturing specifications.
Event or Problem Description
An 87-year-old female patient was undergoing a thrombectomy procedure to treat an occlusion at the terminus internal carotid artery (ica).The physician initially could not advance the zoom 88 access catheter past the horizontal petrous.After the physician's third attempt, a competitor's guidewire, zoom 55 and zoom 35 aspiration catheters were inserted.This allowed the zoom 88 to move past the horizontal petrous and advance up to the cavernous.The physician noted atherosclerosis and a diseased ica.The physician had a dual aspiration set-up with the zoom 88 access catheter and zoom 55 aspiration catheter.The zoom 55 and zoom 35 aspiration catheters were advanced over the competitor guidewire to the face of the clot in the terminus ica.Zoom 35 was removed.Engaging the clot with zoom 55, the physician started aspiration and retracted the zoom 55 catheter with the clot to the zoom 88.A second aspiration was started with the zoom 88 as the zoom 55 and clot were retracted through the access catheter (zoom 88).During a contrast run, another occlusion was observed in the m1 segment.On its second pass, the physician successfully advanced the same zoom 55 to the m1 segment and aspirated the clot.After another contrast run a third occlusion was found in the m2/m3 bifurcation.The physician attempted a third pass with the same zoom 55 aspiration catheter; however, was not able to aspirate the clot.Using a competitor's revascularization device through the same zoom 55, the physician performed three more passes to try and retrieve the clot; however, without success.On the last pass, during the reperfusion run, the physician noticed a potential dissection at the inferior lacerum above the horizontal petrous, as well as a pre-existing aneurysm.The physician deployed a flow divertor stent and balloon to recanalize the lacerum.Following this, a pre-existing aneurysm was also observed at the carotid siphon.During the final contrast run, there was no extravasation noted on the imaging.Tici 2b score was achieved.There were no device malfunctions reported.The patient passed away the following day due to intracranial bleeding.The physician indicated that the bleeding was probably due to hemorrhagic conversion of the stroke and confirmed that it was not related to the zoom 88 catheter.According to the physician, the patient was administered a strong blood thinner (0.10 microgram of aggrastat) that would not have otherwise been used, and that possibly the small hemorrhage became a fatal hemorrhage due to the dissection.The anticoagulation was administered (as physician protocol) before stent deployment.

• Brand Name: ZOOM ¿ 88 LARGE DISTAL PLATFORM
• Common Device Name: GUIDE CATHETER
• 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 avenue; campbell, CA 95008-6609
• MDR Report Key: 16508347
• Report Number: 3014590708-2023-00006
• Device Sequence Number: 6919278
• Product Code: QJP
• UDI-Device Identifier: 00812212030368
• UDI-Public: 00812212030368
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K212224
• 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): 03/08/2023

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: 12/06/2023
• Device Model Number: ICTC088110
• Device Catalogue Number: ICTC088110
• Device Lot Number: F2233901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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: 6F SIM SELECT; 8F SHORT SHEATH; GLIDEWIRE ADVANTAGE; PENUMBRA 3D REVASCULARIZATION DEVICE; SURPASS FLOW DIVERTOR STENT; SYNCHRO ADVANCED 0.014"; ZOOM 35; ZOOM 55
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female