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	Perforation of Vessels (2135)
Date of Event	02/11/2024
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 45.Based on the limited case image and information provided, the exact cause of the vessel perforation is unknown.The relationship with the zoom device to the vessel perforation could not be established.It is unclear if the perforation was caused by the zoom device or other devices.The manufacturing records for the zoom 45 device were reviewed and demonstrated that the product met all design and manufacturing specifications.
Event or Problem Description
During an in-service visit, the physician reported to the imperative care sales representative about a vessel perforation event that occurred "a few months ago" with a zoom 45 catheter.The clot location was in the inferior distal m2 segment.During the first pass, the physician used a third-party access catheter and two different size aspiration catheters over a guidewire, but they could not advance.Both aspiration catheters were removed from the patient.With the same third-party access catheter in place, the physician then advanced a zoom 45 catheter over a third-party microcatheter and guidewire to the face of the clot in the m2 segment.The microcatheter and guidewire were then removed from the patient.Aspiration was applied to the zoom 45.The physician does not know if the clot was removed.Post-aspiration imaging revealed a vessel perforation of the distal m2 segment.The patient became unstable, and the physician ended the procedure.There was no treatment administered.The physician indicated that the patient was elderly and had tortuous anatomy with fragile vessels.The physician was not sure if the zoom 45 had caused the vessel perforation.No device deficiency was reported.The patient passed away due to cardiac arrest at an unknown time on the same day.

• 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: 19639452
• Report Number: 3014590708-2024-00020
• Device Sequence Number: 15303767
• Product Code: NRY
• UDI-Device Identifier: 00812212030498
• UDI-Public: 00812212030498
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/28/2024

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: 10/05/2024
• Device Model Number: ICRC045144
• Device Catalogue Number: ICRC045144
• Device Lot Number: F2326202
• 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: 05/30/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2023
• 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: ARISTOTLE 24 GUIDEWIRE; PHENOM 27 MICROCATHETER; RED 43; RED 62
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 86 YR
• Patient Sex: Female