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

Model Number	ICRC045144
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	05/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 63-year-old male was treated for an occlusion at the m1 segment.Access was obtained with a zoom 88 access catheter over a guidewire.A zoom 71 was advanced over the guidewire to the face of the clot.The zoom 88 was then advanced over the zoom 71 and was positioned proximal to the m1 segment clot.The guidewire and zoom 71 were removed from the patient and aspiration was applied to the zoom 88 for approximately two minutes.Some clot was removed.An angiogram revealed recanalization was not achieved.A second pass was performed with the same zoom 88 and guidewire.The same zoom 71 was advanced to the face of the clot.The zoom 88 was advanced over the zoom 71 into the proximal m1 segment.The guidewire and zoom 71 were removed from the patient.The zoom 88 was connected to the zoom pump and aspiration was applied for approximately two minutes.The clot was removed.An angiogram revealed recanalization of the m1 segment, and a tici 2b score was achieved.An angiogram revealed another occlusion at distal m3 segment.A third pass was performed using the same guidewire and zoom 88.A zoom 45 was advanced over the guidewire through the zoom 88.The zoom 88 was positioned in the cavernous ica (internal carotid artery).The guidewire was advanced to the m3 segment to the face of the clot but did not cross the clot.The zoom 45 was advanced over the guidewire to the m3 segment, and the guidewire was then removed.Aspiration was applied for approximately 90 seconds to the zoom 45 and then the catheter was removed.A follow-up contrast run revealed extravasation in the m3 region.No hemodynamic changes were noted.Protamine was administered and tpa reversed.After several runs, the extravasation was observed to have stopped spontaneously.A final tici 2b score was achieved.There was no report of a device malfunction.No other patient sequelae were reported.
Additional Manufacturer Narrative
The device was discarded after use and therefore not available for return and investigation.A device lot number was not provided.All devices undergo appropriate testing and inspection per standard manufacturing processes to ensure the device meets specifications prior to release.Based on operative notes, there was no evidence of extravasation until after the third pass.The cause of the extravasation is unknown.Based on the information provided, both the guidewire and zoom 45 were present at the location of the extravasation in the m3 region.No device deficiencies reported related to any of the zoom devices.

• 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: 17233067
• Report Number: 3014590708-2023-00021
• Device Sequence Number: 12578481
• Product Code: NRY
• UDI-Device Identifier: 00812212030498
• UDI-Public: 00812212030498
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/29/2023

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: 11/14/2023
• Device Model Number: ICRC045144
• Device Catalogue Number: ICRC045144
• Device Lot Number: F2231301
• 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: 06/02/2023
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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: LONG SHEATH; SCIENTIA VASCULAR ARISTOTLE GUIDEWIRE; ZOOM 71; ZOOM 88; ZOOM PUMP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American