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	Vascular Dissection (3160)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an occlusion in the right m2.First, four passes were conducted with two sizes of stent retrievers and competitor's 5f and 6f aspiration catheters.After the four unsuccessful attempts to open the occlusion, a zoom 45 aspiration catheter was successfully used to remove the clot and flow was restored.The physician observed a vessel dissection during the routine contrast run performed post clot removal.A stent was then placed through the vessel and flow was confirmed.There were no device deficiencies reported.On (b)(6) 2022, the patient was discharged to rehab, and the stent was reportedly open.
Additional Manufacturer Narrative
The device was discarded after use and therefore not available for return and investigation.No additional information could be obtained.There were no device deficiencies reported related to the zoom 45.Based on the information reported, four unsuccessful passes were made with competitor's devices before introduction of zoom 45.Zoom 45 was eventually used to restore the flow.Since limited information was provided about the case, the device was not returned for investigation, and limited case images provided, the relationship with zoom 45 to the dissection could not be established and it is not clear if the competitor's devices used earlier in the case could have caused or contributed to the dissection.The manufacturing records of this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection were completed prior to release to ensure the device met specifications.

• 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 avenue; campbell, CA 95008-6609
• MDR Report Key: 14382925
• Report Number: 3014590708-2022-00009
• Device Sequence Number: 4859592
• Product Code: NRY
• UDI-Device Identifier: 00812212030276
• UDI-Public: 812212030276
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/12/2022

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: 05/21/2022
• Device Model Number: ICRC045144
• Device Catalogue Number: ICRC045144
• Device Lot Number: F2114001
• 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: 04/13/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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: SOFIA 5F CATHETER; SOFIA 6F CATHETER; SOLITAIRE 3/20 STENT RETRIEVER; SOLITAIRE 4/40 STENT RETRIEVER; WALRUS BGC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown