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

Model Number	ICRC07X137
Medical Device Problem Codes	Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a mechanical thrombectomy of the m1 segment using zoom 88, along with a third party access catheter and sheath.Stenosis of the carotid artery was noted.The physician advanced the zoom 7x over a zoom 35 and third party wire to the m1 clot and successfully retrieved the clot.A remaining clot was identified in the m2 segment.The physician then used a zoom 35 and a third party wire to advance the 7x to the clot in the m2.On second pass, the physician removed zoom 7x and noticed that the tip was missing and was lodged in the m2/m1/ica.The physician advanced the zoom 88 to the detached tip and successfully removed it by aspirating through zoom 88.Full reperfusion of both the m1 and m2 segments was achieved.A total of two passes were completed for the procedure.The patient's post procedure status was reported as stable.
Additional Manufacturer Narrative
The zoom 7x was not returned for investigation.The manufacturing records were reviewed and showed the product met the design and manufacturing specifications.Without the return of the device, the exact root cause for the shaft break could not be determined.However, based on the available information, the presence of carotid artery stenosis was likely a contributing factor to the event.
Additional Manufacturer Narrative
The following fields were updated: b4: date of this report d9: is this device available for evaluation? g3: date received by manufacturer g6: type of report h2: if follow-up, what type? h3: device evaluated by manufacturer h6: adverse event problem codes h11: additional manufacturer narrative the zoom 7x was returned separated into three segments.An additional break occurred during the decontamination process due to excessive manipulation during flushing.Images of the device taken prior to decontamination were used to confirm identification of the original catheter shaft fracture segments.Device investigation identified damage consistent with the application of axial force during the procedure, resulting in stretching of the shaft materials prior to fracture.Kink damage was observed on the proximal segment, and tip damage was noted on the distal segment.Review of the manufacturing records for the zoom 7x confirmed that the product met all design and manufacturing specifications.The exact root cause of the shaft fracture could not be determined from the device investigation.Complaint information indicates that the rotating hemostasis valve (touhy) may have been overtightened during removal of the zoom 7x after the first pass.However, this 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: 24595784
• Report Number: 3014590708-2026-00009
• Device Sequence Number: 18408967
• Product Code: NRY
• UDI-Device Identifier: 00812212030757
• UDI-Public: (01)00812212030757(17)260728(10)F2520501
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/05/2026

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 Model Number: ICRC07X137
• Device Catalogue Number: ICRC07X137
• Device Lot Number: F2520501
• 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: 02/15/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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 45CM DESTINATION SHEATH; ARISTOTLE 24 WIRE; PENUMBRA SELECT VRT CATHETER; ZOOM 35; ZOOM 88
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown