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	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a mechanical thrombectomy procedure for a left m1 occlusion, the patient was noted to have a tandem occlusion with 97% occlusion of the internal carotid artery (ica), as well as severe tortuosity and stenosis of the cervical internal carotid artery (ica).After unsuccessful passes with two other third-party catheters, the physician selected a zoom 7x catheter.During the procedure, the third-party guide catheter positioned in the cervical ica prolapsed and lost its position.The physician subsequently removed the guide catheter and zoom 7x catheter together as a system.After the system was removed from the patient, the tip of the zoom 7x became stuck within the third-party guide catheter.While attempting to remove the zoom 7x catheter for use with another guide catheter, the catheter shaft separated.The reported break occurred outside the patient, and no intervention was needed.The physician then used a zoom support catheter and another zoom 7x to successfully complete the procedure.The patient was reported to be stable post-procedure.
Additional Manufacturer Narrative
A zoom 7x device was returned for investigation.The device was received separated into distal and proximal catheter segments, confirming shaft separation.Examination of the returned device identified catheter shaft damage consistent with axial loading during use, including elongation and stretching of the catheter jacket material at the separation location.Additional findings included kinking and tip damage on the distal segment.The complaint reported that a third-party guide catheter had prolapsed and lost position.After the system was removed from the patient, the zoom 7x became stuck within the third-party guide catheter and subsequently separated during an attempt to remove it.Based on the available information, a definitive root cause could not be established.However, the investigation determined that the reported shaft separation was likely related to an interaction between the prolapsed third-party guide catheter and the zoom 7x.Manufacturing records were reviewed and confirmed the product met all design and manufacturing specifications prior to release.

• 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: 25326216
• Report Number: 3014590708-2026-00021
• Device Sequence Number: 9805782
• Product Code: NRY
• UDI-Device Identifier: 00812212030757
• UDI-Public: (01)00812212030757(17)270126(10)F2602202
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 05/28/2026

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: ICRC07X137
• Device Catalogue Number: ICRC07X137
• Device Lot Number: F2602202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2026
• 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: MEDTRONIC APRO.; RED 68.; STRYKER SYNCHRO SELECT .014" WIRE.; STRYKER TREVO NXT 6MM X 37MM.; STRYKER TREVO TRACK 21.; WALRUS BGC.; ZOOM 7X.; ZOOM SUPPORT.
• Patient Age: 73 YR
• Patient Sex: Male