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

Model Number	ICRC035158
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoom 35, zoom 55 and competitor stent retriever were returned for analysis.The zoom 88 access catheter was not returned for evaluation.The zoom 35 was returned with a distal segment of the outer jacket and marker band detached.The detached distal segment was found wrapped and tangled in the expanded frame of the stent retriever.The zoom 55 was returned with the distal tip marker band damaged.The exact root cause of shaft breakage could not be determined.The manufacturing records of the zoom 35 and zoom 55 were reviewed and demonstrated the products met all the design and manufacturing specifications.
Event or Problem Description
A 93-year-old patient was undergoing a thrombectomy procedure to treat an occlusion at the m2 segment.During the first pass, zoom 88 access catheter was advanced to the cavernous internal carotid artery (ica).The physician successfully navigated zoom 55 and zoom 35 over a guidewire to the face of the distal occlusion.The physician reported that when she removed the zoom 35, the distal portion of the catheter was missing.Imaging showed that the distal portion of the zoom 35 catheter was in the m2 segment.On the second pass, the physician advanced a stent retriever through the zoom 55 and the occlusion.The stent retriever captured the distal part of the zoom 35 from the m2 segment and was removed from the patient's body.The stent retriever did not remove the clot as there was no back flow of blood noted during aspiration.The physician speculated that the clot was very hard and calcified.She examined the zoom 88 afterwards and noted no issues with the device.The zoom 55 distal tip was observed to be damaged (deformed?).She reported there was no resistance felt while advancing the system or when removing the zoom 35 from the zoom 55.The case was completed after the unsuccessful attempt to remove the clot with the stent retriever.The patient was discharged home on (b)(6) 2023, under cmo (comfort measure only).
Additional Manufacturer Narrative
A user facility medwatch report was received with the date of event as 01/02/2023.After confirmation from the account the date of event was corrected from 01/01/2023 to 01/02/2023.

• 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 ave; campbell CA 65008 6609
• Manufacturer Contact: joy patel ; 1359 dell avenue; campbell, CA 95008-6609
• MDR Report Key: 16285919
• Report Number: 3014590708-2023-00001
• Device Sequence Number: 5020077
• Product Code: NRY
• UDI-Device Identifier: 00812212030443
• UDI-Public: 00812212030443
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: ICRC035158
• Device Catalogue Number: ICRC035158
• Device Lot Number: F2227102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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: SYNCHRO GUIDE WIRE; TREVO STENT RETRIVER; ZOOM 55; ZOOM 88
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male