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	Vascular Dissection (3160)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
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 71.Based on the information provided, five unsuccessful passes were made with a combination of competitor's devices before using zoom 71.Zoom 71 was finally used successfully to restore blood flow.Since limited information was provided about the case, the device was not returned for investigation, and limited case images were provided, the relationship with zoom 71 to the dissection could not be established as 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 and confirmed that appropriate testing and inspection were completed prior to release to ensure the devices in the lot met specifications.
Event or Problem Description
The patient was being treated for an occlusion at the right internal carotid artery (ica) m2 segment.The patient had a history of septic emboli, "bad" endocarditis, and was an iv drug user.Access was obtained using a guidewire, competitor guide catheter and competitor large bore catheter.The physician stated that he had difficulty advancing the guidewire but was subsequently able to make five unsuccessful passes with a combination of competitor guide catheter, stent retriever and aspiration catheters.A zoom 71 aspiration catheter was next advanced to the vessel and flow was restored.Subsequently the vessel shut down which was attributed to a vessel dissection.A stent was then placed in the vessel and flow was restored.The patient was transferred to the icu ward because of complicated endocarditis.

• 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: 14383101
• Report Number: 3014590708-2022-00010
• Device Sequence Number: 15139346
• Product Code: NRY
• UDI-Device Identifier: 00812212030191
• UDI-Public: 00812212030191
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 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: 08/28/2022
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2123601
• 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: 08/28/2021
• 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: CATALYST 5; GUIDEWIRE (UNKNOWN BRAND); LBC CERENOVOUS; SOLITAIRE; TREVO 4-14; WALRUS BALLOON CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male