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

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was treated for an occlusion in the left proximal middle cerebral artery/m1 segment.Access was obtained with a guidewire, a microcatheter, and a tracstar access catheter to the left common carotid artery (cca).During the first pass, the guidewire and the microcatheter were removed and a 0.035" guidewire and a zoom 71 catheter were advanced through the tracstar to the left cca.A zoom 35 catheter was then advanced through the zoom 71 and during advancement the physician felt resistance in the left cca.The patient's anatomy did not exhibit tortuosity, stenosis, or calcification.The physician proceeded to remove the guidewire, the zoom 35, and then the zoom 71 without performing aspiration.Upon removal, the physician noted that approximately 10 cm portion of the zoom 71 catheter had separated inside the tracstar.The physician retracted the separated zoom 71 and tracstar as a system.After the removal of the zoom 71 and tracstar devices, a kink was noted on the tracstar.Per the physician, the kink was not observed during the case.The physician proceeded with the case using a new tracstar and zoom 71.After aspiration, the clot was successfully removed, and the patient achieved complete reperfusion with a tici 3 score.No patient sequelae were reported.
Additional Manufacturer Narrative
The zoom 71 catheter was returned for investigation.Investigation confirmed the reported shaft breakage that occurred and suggested that an axial force was applied, stretching the shaft materials prior to breaking.Investigation demonstrated stretching and kinking along both the distal and proximal segments of the broken catheter shaft.Stretched catheter jacket materials were observed on both the distal and proximal segments of the zoom 71.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.Without any case images and based on the complaint information provided, the exact root cause could not be determined.

• 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: 19239121
• Report Number: 3014590708-2024-00017
• Device Sequence Number: 8049190
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2024
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2328301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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: 0.035" COLOSSUS GUIDEWIRE; TRACSTAR
• Patient Sex: Unknown