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

Model Number	ICRC055137
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an occlusion in the left inferior division m2 segment.Access was obtained with a zoom 88 guide catheter over a glidewire.The zoom 88 was positioned in the proximal cervical internal carotid artery (ica) and the glidewire was removed.A guidewire, third-party microcatheter, and a zoom 55 aspiration catheter were advanced to the face of the clot.The microcatheter and guidewire were then removed, and manual aspiration was applied to the zoom 55.Angiography was performed, and no significant change was observed.During the second pass, the treating physician removed the zoom 55 and advanced a zoom 71 and applied manual aspiration using the same process as in the first pass.Angiography was repeated and evidence of stenosis/dissection was observed in the superior m2 segment, which the physician attributed to catheter agitation.For the third pass, the zoom 71 was removed, and the same zoom 55 was advanced over the same guidewire.A new third-party microcatheter and a stent retriever were then advanced to the face of the clot.Aspiration was applied to the zoom 55.Angiography showed the occlusion had worsened and was now down to the origin of the inferior m2 segment.In the fourth pass, the zoom 55 was removed from the patient, and the procedure was completed using a third-party aspiration catheter, zoom 88 and third-party microcatheter angiography demonstrated successful recanalization consistent with tici 2c flow; however, there was evidence of dissection/stenosis beyond the origin of the left inferior m2 segment.It is unknown if the dissection/stenosis was present prior to the procedure.Approximately 5 milligram of verapamil was administered to slow down the blood flow.No device malfunctions were reported, and all devices were discarded.Two days post procedure, the patient was discharged without any patient sequelae.
Additional Manufacturer Narrative
The devices were discarded after use and therefore not available for return and investigation.There were no device deficiencies reported related to the zoom 71 or zoom 55.The exact root cause for the dissection is unknown.Based on the case images and information provided it is unclear if the dissection/stenosis was present prior to the procedure or caused by the zoom devices, guidewire, or third-party aspiration catheter.The manufacturing records for the zoom devices were reviewed and demonstrated that the product met all the design and manufacturing specifications.The following mfr # were submitted: (b)(4).

• 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: 19148568
• Report Number: 3014590708-2024-00015
• Device Sequence Number: 7406835
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: 00812212030474
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/19/2024

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: 11/10/2024
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2330601
• 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: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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: 0.035" TERUMO GLIDE ADVANTAGE WIRE; 0.038" BENTSON GUIDEWIRE; 25 CM 5F COOK BERENSTEIN CATHETER; 8F ANGIO-SEAL CLOSURE DEVICE; 8F SHORT TERUMO PINNACLE; ARISTOTOLE 14; PHENOM 27; RED 63; TIGER 17 THROMBECTOMY DEVICE; ZOOM 71; ZOOM 88 GUIDE CATHETER; ZOOM ASPIRATION TUBING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 98 KG