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	08/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician performed a left m1 mechanical thrombectomy with zoom 7x, a third-party guidewire and access catheter using dual aspiration.During removal of the zoom 7x through the rhv, the distal portion of the zoom 7x catheter became stuck and separated.The physician removed the rhv to retrieve the distal segment of the zoom 7x.No further intervention was required, as the procedure was successfully completed in a single pass.There was no patient sequelea.
Additional Manufacturer Narrative
The distal segment of the zoom 7x catheter shaft was not returned for investigation.The zoom 7x 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.Kink damage was observed on the proximal end of the returned device.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.Without return of the rhv (unknown make/model), the exact root cause for the shaft break could not be determined from the device investigation.Limited case information indicated that the zoom 7x had become stuck in the rhv during removal resulting in the catheter break.

• 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: 23009899
• Report Number: 3014590708-2025-00020
• Device Sequence Number: 16077937
• Product Code: NRY
• UDI-Device Identifier: 00812212030757
• UDI-Public: (01)00812212030757(17)260623(10)F2516701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/09/2025

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 Expiration Date: 06/23/2026
• Device Model Number: ICRC07X137
• Device Catalogue Number: ICRC07X137
• Device Lot Number: F2516701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ARISTOTLE 24; BALLAST SHEATH; ZOOM DUOPORT; ZOOM PODS
• Patient Sex: Unknown