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 Code	Perforation of Vessels (2135)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
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.Based on the information provided and without case images, the exact cause of the vessel perforation is unknown.The relationship with the zoom 71 device to the vessel perforation could not be established.It is unclear if the perforation was caused by the zoom 71 device or other devices.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.
Event or Problem Description
A patient was treated for an occlusion in the right m1 segment.Ct scan revealed an extremely dense and calcified clot.A third-party insert catheter and zoom 88 access catheter were introduced over a glidewire and the system was advanced over the aortic arch and into the cervical region.The third-party insert catheter was then removed.A zoom 71 aspiration catheter was navigated over a third-party microcatheter and microwire through the zoom 88.The zoom 71 aspiration catheter was advanced into the m1 segment to the face of the clot.Aspiration was applied to the zoom 71.After three passes, no meaningful reperfusion was achieved.During the fourth pass, the physician advanced the same zoom 71 over the same third-party microcatheter and microwire to the face of the clot.The physician then crossed the clot with the third-party microcatheter and microwire, going out the superior trunk of the middle cerebral artery (mca).The microwire was removed and a stent retriever was advanced through the microcatheter.The stent retriever was deployed along the entire m1 segment.The zoom 71 was then positioned to ensure it was at the face of the clot, trapping the clot between the stent retriever and the aspiration catheter.The physician removed the zoom 71 and stent retriever simultaneously under aspiration.Intermittent angiography demonstrated tici 2a recanalization.Active extravasation was suspected, the physician advanced the same third-party microcatheter and deployed a 3.5 mm x 10 cm ev3 coil in the distal right m1 segment.Intermittent angiography was performed that demonstrated reduction in extravasation without significant impact on distal mca perfusion.The physician observed flow in this territory with the coil in place for approximately 5 minutes before removing it.Angiography was performed, and no further extravasation noted.All the catheters were removed.There were no device issues and no other patient sequelae reported.

• 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 95008-6609
• MDR Report Key: 19745960
• Report Number: 3014590708-2024-00021
• Device Sequence Number: 9015702
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2023
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2213602
• 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: 06/20/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2022
• 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: 3.5 MM X 10 CM EV3 AXIUM PRIME COIL; 5F VTK; SOLITAIRE STENT RETRIEVER; SYNCHRO GUIDEWIRE; VELOCITY MICROCATHETER; ZOOM 88
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 58 KG