MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM CATHETER

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A zoom 71 device was returned for investigation.The device was received without the distal tip, confirming distal tip/marker band separation.Examination of the returned device identified separation at the location where the marker band detached from the distal end of the catheter shaft.The separation location exhibited minimal stretching of the catheter materials.The catheter shaft exhibited multiple kinks on the proximal end and stretching of catheter shaft materials on the distal end.Based on the available information and evaluation of the returned device, a definitive root cause for the distal tip detachment could not be established.Examination confirmed the reported failure mode and indicated that separation occurred at the marker band/distal tip attachment interface.Complaint information identified several contributing factors that may have contributed to the reported event.The zoom 71 was tracked in a kink third-party access catheter in the presence of mildly tortuous anatomy and resistance was reportedly encountered during advancement and retraction.The zoom system instructions for use (ifu) warns, "exercise care when manipulating the device through tortuous anatomy.Do not advance or withdraw the catheters or accessory/adjunctive devices against resistance without careful assessment of the cause under fluoroscopy.If the cause cannot be determined, withdraw all devices as a single unit.Excessive manipulation or torquing of the device against resistance may result in damage to the vasculature or the device." manufacturing records were reviewed and confirmed the product met all design and manufacturing specifications prior to release.
Event or Problem Description
During a mechanical thrombectomy procedure for a left proximal m1 occlusion, access was obtained via the right radial artery using a third-party access guide catheter.During the second pass, resistance was encountered while withdrawing the zoom 71 through the third-party guide catheter.It was reported that the third-party guide catheter had kinked, causing the distal tip of the zoom 71 to fracture near the kink site.The broken piece was successfully retrieved using an additional aspiration catheter.The physician then exchanged for an alternative third-party device and successfully completed the procedure.The patient remained stable following the event, with no reported adverse clinical outcome.

• 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: 25672889
• Report Number: 3014590708-2026-00025
• Device Sequence Number: 18753844
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: (01)00812212030450(17)260608(10)F2409203
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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 Expiration Date: 06/08/2026
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2409203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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: Q'APEL ZEBRA RADIAL ACCESS GUIDE CATHETER.; SOLITAIRE STENT RETRIEVER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female