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

Model Number	ICRC07X137
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with stroke-like symptoms, including a chronic occlusion on the left side and an acute stroke on the right side.The physician initially performed two passes using third-party devices.After the second pass, partial opening of the m1 segment was observed.The physician removed the devices as a system, and a subsequent run revealed a bleed after the second pass.For the third pass, zoom 7x was used over the third-party reperfusion catheter.Following third pass, bleeding was noted at the internal carotid artery (ica) m1 terminus segment.An additional third-party device was placed to control the bleed.Once bleeding was controlled, the m1 segment remained occluded, so the physician proceeded with fourth and fifth passes using third-party devices with aspiration.After the fifth pass, the patient experienced rebleeding, and an additional third-party device was placed to control the rebleeding.Upon follow-up, the physician reported that the patient passed away on (b)(6) 2025, due to the severity of the ischemic stroke, not a device related complication.There were no malfunctions noted with the zoom 7x during the procedure.
Additional Manufacturer Narrative
A zoom 7x was returned for investigation.No damage to the device was observed.Inspection of the interior and exterior of the returned zoom 7x catheter shaft did not exhibit any signs of damage.The manufacturing records for zoom 7x were reviewed and demonstrated that the product met all the design and manufacturing specifications.Based on the reported complaint information, the root cause for the reported hemorrhage could not be determined.No device malfunction was reported.The reported complaint noted that the cause of death was due to severity of the ischemic stroke, not a device related complication.
Additional Manufacturer Narrative
The following fields were updated: b4: date of this report g6: type of report h2: if follow-up, what type? h11: additional manufacturer narrative following an internal review on december 12, 2025, there was an inadvertent entry error noted for b4 'date of this report'.This supplemental mdr is being submitted to correct the 'date of report' to november 25, 2025.There are no changes to the information, facts, or conclusions reported in the original initial mdr.

• 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: 23653136
• Report Number: 3014590708-2025-00026
• Device Sequence Number: 15943070
• Product Code: NRY
• UDI-Device Identifier: 00812212030757
• UDI-Public: (01)00812212030757(17)260630(10)F2517701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/25/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: ICRC07X137
• Device Catalogue Number: ICRC07X137
• Device Lot Number: F2517701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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 SHUTTLE SHEATH.; CHIKAI BLACK 14 WIRE.; PERFUZE MILLIPEDE 88 CATHETER.; RED 43 CATHETER.; SCEPTOR 4 X15.; ZIPLINE 88 CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Unknown