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

Model Number	ICRC07X137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoom 7x was not returned for investigation.The manufacturing records confirmed the product met all the design and manufacturing specifications.The zoom system ifu warns, "zoom system catheters are not recommended for use in combination with stent-retrievers." and "do not perform more than 3 clot retrieval attempts with the zoom system." additionally, "exercise care when manipulating the device through tortuous anatomy." based on the available information, a definitive root cause could not be established.However, it is likely that resistance encountered within the stent retriever and tortuous anatomy contributed to the reported event.
Event or Problem Description
It was reported that during a mechanical thrombectomy procedure for an internal carotid artery (ica) terminus occlusion extending into the distal m1/proximal m2 segment, the zoom 7x catheter separated during the eighth pass while being used with a third-party stent retriever.The separation occurred proximal to the gray segment of zoom 7x.Resistance was noted during retraction of the stent retriever.The separated catheter segment was identified within the zoom 88 support catheter after case completion and removal of the system from the patient.The distal piece was retrieved by flushing the zoom support catheter outside the patient.The patient was reported to be stable post-procedure.The anatomy was described as severely tortuous, including a 360-degree loop in the internal carotid artery (ica) and a double s-shaped configuration.

• 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: 25250178
• Report Number: 3014590708-2026-00017
• Device Sequence Number: 16085686
• Product Code: NRY
• UDI-Device Identifier: 00812212030757
• UDI-Public: (01)00812212030757(17)261103(10)F2530402
• 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): 05/21/2026

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: F2530402
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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 .024" WIRE.; BOSTON SCIENTIFIC FATHOM .016" WIRE.; CERENOVOUS EMBOTRAP 6.5MM X 45MM.; EV3 REBAR 18 MICROCATHETER.; MEDTRONIC SOLITAIRE X SFR4-6-40-10.; ZOOM DUOPORT.; ZOOM POD.; ZOOM SUPPORT.
• Patient Age: 62 YR
• Patient Sex: Female