MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM 7X CATHETER

Model Number	ICRC07X137
Medical Device Problem Codes	Break (1069); Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for investigation.The manufacturing records were reviewed and demonstrated that the product met the design and manufacturing specifications.Based on the information provided, the exact root cause of the shaft break could not be determined.Limited information available indicated that the patient had tortuous anatomy and retraction of the zoom 7x against resistance which could have contributed to the reported event.The zoom ifu provides the following warning related to retraction against 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 the patient presented with an m1 occlusion, severe carotid stenosis and stroke-like symptoms.The carotid artery stenosis and third-party sheath placement restricted the advancement of zoom 88 access catheter.Zoom 7x navigated through significant vessel tortuosity and a 360-degree curvature; the procedure was completed in a single aspiration pass.During retraction of the zoom 7x, resistance was encountered, and the catheter tip was found to be damaged upon removal of the device from the patient.Imaging revealed that the catheter tip remained in the patient's m1 segment.The physician then introduced a zoom 55 catheter through the zoom 88 to engage the detached tip and successfully retrieved the entire segment.The patient achieved successful reperfusion and there was no patient sequela.
Additional Manufacturer Narrative
A proximal segment of the zoom 7x was returned for evaluation.The investigation of the returned proximal segment demonstrated damage which suggests an axial force was applied during the procedure, resulting in stretching of shaft materials prior to the device breaking.Additionally, multiple kinks were present on the returned catheter segment.Investigation confirmed that the distal section of catheter had separated from the proximal segment.Therefore, the break happened in the catheter shaft and not the tip as originally reported.The distal segment was not returned for investigation.Based on the review of the returned proximal segment, the exact root cause for the broken shaft could not be confirmed.

• Brand Name: ZOOM 7X CATHETER
• Common Device Name: ZOOM 7X 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: 23708483
• Report Number: 3014590708-2025-00028
• Device Sequence Number: 10596003
• Product Code: NRY
• UDI-Device Identifier: 00812212030757
• UDI-Public: (01)00812212030757(17)260711(10)F2518901
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K243047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 07/11/2026
• Device Model Number: ICRC07X137
• Device Catalogue Number: ICRC07X137
• Device Lot Number: F2518901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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: ARISTOTLE 24 GUIDEWIRE; ARROW SHEATH 8F; ZOOM 55; ZOOM 88; ZOOM DUOPORT; ZOOM SIM INSERT CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: White