MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM REPERFUSION CATHETER; 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	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an occlusion at a very distal location (exact location of the clot not provided).The patient reportedly had a tortuous anatomy.Access was obtained with zoom 88 which was parked at the distal ica/terminus.The zoom 55 was initially tracked only over a.016" guidewire without another catheter inside it for support.Resistance was felt when advancing the zoom 55 over the wire.The physician believed the zoom 55 might have been too large for the target vessel and thought about switching to a zoom 45.Instead, he decided to perform two passes with the zoom 55 without performing aspiration.On the 3rd pass, a zoom 35 was introduced inside of zoom 55 to make zoom 55 track more distally.More resistance was felt when zoom 35 was introduced inside of zoom 55.The physician removed both zoom 55 and zoom 35 as a system.When the zoom 35 was removed from zoom 55 outside the patient, the tip of the zoom 55 inverted/accordioned on itself.Outside of the patient, when the physician tried to manually straighten the tip of the zoom 55, it broke several centimeters back from the distal tip.A zoom 45 was then used to complete the procedure.There was no patient sequelae reported.
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.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 with limited case images, the exact root cause could not be determined.The most likely cause for the shaft break was advancement of the zoom 55 against resistance within a tortuous vessel that may have been too small for the outer diameter of the zoom 55 and subsequent manual straightening of the catheter tip after removal from the patient.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.

• 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: joy patel ; 1359 dell ave; campbell, CA 95008-6609 ; 4082029060
• MDR Report Key: 21671618
• Report Number: 3014590708-2025-00006
• Device Sequence Number: 4479017
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: (01)00812212030474(17)271021(10)F2429101
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/21/2025

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 Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2429101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FATHOM .016" WIRE; ZOOM 35; ZOOM 45; ZOOM 88
• Patient Sex: Unknown