MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM CATHETER

Model Number	ICRC071137
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	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distal segment of the zoom 71 catheter shaft was not returned for investigation.The zoom 71 proximal segment was returned and device investigation confirmed shaft breakage and suggested that an axial force was applied during the procedure resulting in separation of the distal segment.Stretching and kink damage was observed on the proximal end of the returned device near the break location.Although the root cause could not be established, the most likely cause is related to a tightened rhv during retraction of the zoom 71.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.
Event or Problem Description
It was reported that during a mechanical thrombectomy procedure for m1 segment, the zoom 71 catheter was removed and observed to have unraveled outside the patient.A total of two passes were performed, with the issue occurring on the second pass.Upon removal, damage was identified approximately 4 cm from the distal tip.Resistance was encountered during retraction through the third party rotating hemostatic valve (rhv).The physician used another zoom 71 to complete the procedure.The case involved significant vessel tortuosity; however, it is unknown whether patient anatomy directly contributed to the event.The patient outcome was reported as poor but was assessed as unrelated to the device issue.Patient was reported to be stable post procedure.

• Brand Name: ZOOM CATHETER
• Common Device Name: ZOOM 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: 24974574
• Report Number: 3014590708-2026-00011
• Device Sequence Number: 14691041
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: (01)00812212030450(17)281203(10)F2533601
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K242672
• 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): 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: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2533601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2025
• 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: 8F TERUMO SHEATH; ARISTOTLE .024 WIRE; GATEWAY RHV; ZOOM 35; ZOOM 71; ZOOM 88
• Patient Sex: Unknown