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

Model Number	ICRC055137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoom 55 catheter was returned for investigation.The investigation demonstrated severe damage to the distal and proximal portions of the catheter shaft including stretching, kinking, and separation of the shaft material.The manufacturing records for the zoom 55 were reviewed and demonstrated that the product met all the design and manufacturing specifications.Based on the complaint information provided and device investigation the exact root cause could not be determined.
Event or Problem Description
An 83-year-old patient was undergoing a thrombectomy procedure to treat an occlusion in the distal portions of the m2 segment.The patient had a type 3 arch, and the anatomy was reported to be tortuous.Access was obtained with a tracstar access catheter which was positioned at the petrous cavernous of the internal carotid artery (ica).A zoom 55 catheter was advanced through the tracstar to the face of the clot.A first pass was made with the zoom 55 without any issues.For the second pass, the physician advanced a third party microcatheter and stent retriever through the same zoom 55 to the clot.After the second pass, while retracting the stent retriever into the zoom 55, the distal portion of the zoom 55 shaft deformed and broke approximately 12cm proximal from the distal end of the catheter.With the stent retriever already through the zoom 55, the physician successfully removed the distal segment of the zoom 55 and stent retriever together.The physician did not continue with the procedure.The clot was partially removed, and the patient achieved partial reperfusion with a tici 2a score.The patient was reported stable, and no patient sequelae were reported.

• 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: 16908054
• Report Number: 3014590708-2023-00013
• Device Sequence Number: 6819216
• Product Code: NRY
• UDI-Device Identifier: 00812212030283
• UDI-Public: 00812212030283
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/10/2023

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: 08/27/2023
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2223802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2022
• 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: PHENOM 21; SOLITAIRE STENT RETRIEVER; TRACSTAR 95CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female