MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM REPERFUSION CATHETER

Model Number	ICRC071137
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	11/08/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The first zoom 71 used in the procedure was returned for investigation.Review of the zoom 71 noted damage which suggests an axial force was applied during the procedure, resulting in stretching, twisting and kinking of shaft materials.The distal marker band tip of the device was found to be ovalized and deformed.The manufacturing records for zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.Based on the review of the returned zoom 71, the exact root cause for the perforation, hemorrhage and death cannot be confirmed.There was no indication that the zoom 71 had a direct cause of the reported adverse events.Complaint information noted that the damage observed on the zoom 71 was attributed to tortuous anatomy and that the damage did not affect the outcome of the procedure.As multiple devices were involved in the reported event, a related mdr was submitted for the same patient and incident under reference number: 3014590708-2026-00006.
Event or Problem Description
Thrombectomy was performed for an m1 stroke.The physician utilized a third-party wire, zoom sim and zoom 88.The 88 remained low in the cervical ica while a zoom 71, third-party microcatheter and third-party neuro wire were advanced to the clot.Manual aspiration was performed with a syringe through zoom 71 when the physician felt resistance and slipping of the zoom 88 and the physician lost access.Physician removed everything including the zoom 88.He went back up with a third-party access catheter and a new zoom 71 and was able to open the m1 successfully.There were distal blockages that he attempted to reach with a zoom 55 unsuccessfully, at which point the procedure was stopped.Post procedure, it was noticed that the zoom 88 was kinked mid-shaft and the original zoom 71 was kinked near the distal tip.The kinks on the zoom catheters were attributed to the patient's tortuous anatomy and did not affect the outcome of the procedure.The third-party femoral sheath was also kinked at the groin access site.Post procedure, an intercranial perforation was identified.Additionally, post procedure a rle (right lower extremity) ischemia was noted, and a head ct was performed which confirmed a large 8-9mm parenchymal hemorrhage with ivh (intraventricular hemorrhage) and sah (subarachnoid hemorrhage).The physician did not specify a cause for the perforation and no intervention was performed to treat the perforation.Patient death occurred on (b)(6) 2025 and cause of death is unknown.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: ZOOM REPERFUSION 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: 24325250
• Report Number: 3014590708-2026-00005
• Device Sequence Number: 21213174
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: (01)00812212030450(17)260612(10)F2409603
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/12/2026

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: 06/12/2026
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2409603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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: FEMORAL SHEATH.; MICROCATHETER.; NEURO WIRE.; NEURON MAX.; ZOOM 55.; ZOOM 71.; ZOOM 88.; ZOOM SIM.
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White