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

Model Number	ICRC07X137
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoom 7x was discarded and not returned for investigation.The manufacturing records were reviewed and showed the product met design and manufacturing specifications.Based on the information provided, it is not clear if the dissection was caused by use of a third-party guidewire, zoom 7x, zoom rdl, or extensive movement of the patient.There were no device issues reported for any of the zoom devices used during the case.As multiple devices were involved in the reported event, a related mdr was submitted for the same patient and incident under reference number 3014590708-2025-00024.
Event or Problem Description
It was reported that a dissection occurred in the mid-cervical region during a mechanical thrombectomy procedure.The patient presented with extremely tortuous anatomy and an occluded subclavian artery.During the procedure, the patient became agitated and required intubation.Following aspiration and clot removal from the right m1 segment, the zoom 7x was removed from the patient and the physician observed the dissection upon retracting the zoom rdl guide catheter for imaging.A third-party device was used to resolve the dissection.There were no device malfunctions reported, and the patient was stable post-procedure.According to the physician, multiple factors may have contributed to the dissection, including the use of a third-party guidewire, the zoom 7x, zoom rdl, or the extensive patient movement necessitating intubation.

• 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: 23432602
• Report Number: 3014590708-2025-00025
• Device Sequence Number: 9118730
• Product Code: NRY
• UDI-Device Identifier: 00812212030757
• UDI-Public: (01)00812212030757(17)260623(10)F2516701
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2026
• Device Model Number: ICRC07X137
• Device Catalogue Number: ICRC07X137
• Device Lot Number: F2516701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: 0.035" WIRE; 7F SLENDER; COLOSSUS WIRE; ZOOM RDL; ZOOM VTK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown