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

Model Number	ICRC071137
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	02/15/2024
Type of Reportable Event	Death
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.The manufacturing records for this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.The exact root cause of the vessel dissection and subarachnoid hemorrhage (sah) is unknown.It was reported that after the microwire and microcatheter were advanced across the clot, resistance was later felt while trying to advance the zoom 71 to the face of the clot.Based on the location of the devices provided and with limited case images, it is unclear if the events were caused by the zoom 71, the microwire, stent retriever or the third-party microcatheter.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an occlusion in the right m1 segment.Access was obtained with a third-party guide catheter, third-party 5f catheter, and a guidewire.The guide catheter was positioned at the high cervical of the internal carotid artery (ica) and the guidewire was removed.A microwire, third-party microcatheter, and zoom 71 aspiration catheter, were advanced to the clot, and a stent retriever was deployed using a solumbra technique.During the first pass, a portion of the clot was removed.No issues were reported during the first pass.During the second pass, the same devices and same approach were used.The microwire and third-party microcatheter were advanced across the clot.While advancing the zoom 71 to the face of the clot the physician reported feeling resistance.The microwire was removed and a stent retriever was deployed through the third-party microcatheter.The third-party microcatheter was removed, and the stent retriever was allowed to dwell for 2-4 minutes.The stent retriever and zoom 71 were withdrawn while aspiration was applied to the zoom 71.After the devices were removed, a contrast run was performed through the third-party guide catheter, revealing a vessel dissection in the mid part of the middle cerebral artery (mca) and a subarachnoid hemorrhage (sah) distal to the dissection.The physician prepared balloons to treat the dissection and sah.However, both balloons malfunctioned during preparation.Another contrast run was performed, and imaging showed that the mca had closed.No further passes were attempted, and no tici score was assigned.There was no reported device malfunction.In relation to the dissection and sah, it was reported that the zoom 71 was in the mca, the third-party guide catheter was in the cervical ica, and the microwire, third-party microcatheter, and stent retriever were all through the dissection and distal to it.The treating physician reported that the zoom 71 device was related to the vessel dissection and sah.Four days post-procedure, the patient passed away.The cause of death is attributed to the stroke and hemorrhage.
Additional Manufacturer Narrative
Date of patient's passing was included and appropriate fields were updated.
Event or Problem Description
Refer to h10 for follow-up information.

• 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: 18907485
• Report Number: 3014590708-2024-00012
• Device Sequence Number: 6188910
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K211476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 10/09/2024
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2327201
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• 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" GLIDEWIRE; INFINITY GUIDE CATHETER; PENUMBRA 5F SIM SELECT CATHETER; SYNCHRO GUIDEWIRE; TREVO STENT RETRIEVER; VELOCITY MICROCATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Age: 74 YR
• Patient Sex: Female