MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM REPERFUSION CATHETER

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	06/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoom 55 was returned for investigation.Upon investigation it was confirmed the shaft of the zoom 55 had broken.The break showed stretching of the catheter materials and kinks on the catheter shaft.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 the exact root cause could not be determined.The most likely cause for the shaft break was advancement and/or retraction against resistance of the zoom 55 through a narrowed vessel affected by stenosis.The zoom ifu provides guidance on selection for the appropriate zoom catheter based on the measured vessel size and provides the following warning related to resistance."exercise care when manipulating the device through tortuous anatomy.Do not advance or withdraw the catheters or accessory/adjunctive devices against resistance without careful assessment of the cause under fluoroscopy.If the cause cannot be determined, withdraw all devices as a single unit.Excessive manipulation or torquing the device against resistance may result in damage to the vasculature or the device.
Event or Problem Description
It was reported that a patient with a tandem occlusion in the proximal internal carotid artery (ica) and m1/m2 segment thrombus was treated with mechanical thrombectomy using a third-party access catheter and zoom 55 aspiration catheter.During the procedure, the physician encountered resistance while advancing and retracting the zoom 55 aspiration catheter through the proximal ica stenosis.Upon reaching the clot, aspiration did not work well due to irregular suction; imaging revealed the device had separated.At this point, the physician removed the zoom 55 catheter.Upon review of the angiograph, it was determined the distal segment of the catheter was in the m1 segment of the middle cerebral artery (mca).An attempt was made to retrieve the distal segment using a snare; however, this approach was unsuccessful.A third-party buddy catheter was used to wedge the distal zoom 55 segment within another third-party catheter, and the distal segment was successfully retrieved.The physician used another zoom 55 reperfusion catheter, and the procedure was completed successfully without any patient sequelae.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: ZOOM REPERFUSION CATHETER
• Manufacturer (Section D): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer Contact: katharine treangen ; 1359 dell ave; campbell, CA 95008-6609 ; 4082029060
• MDR Report Key: 22671672
• Report Number: 3014590708-2025-00016
• Device Sequence Number: 7626507
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: (01)00812212030474(17)271205(10)F2432701
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K242672
• 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): 07/30/2025

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 Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2432701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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: ECHO ACCESS CATHETER; GLIDEWIRE; TREVO TRAK MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown