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

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562); Use of Device Problem (1670); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoom 71 was retained by the account and not returned for investigation.The manufacturing records for zoom 71 were reviewed and demonstrated that 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.Based on the information available, likely factors that contributed to the reported complaint were tortuous anatomy in the cervical internal carotid artery, technique and retraction of the zoom 71 against resistance while inside a third-party access catheter.The zoom device ifu provides the following warning related to retraction against resistance."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 the device against resistance may result in damage to the vasculature or the device.".
Event or Problem Description
It was reported that the patient was undergoing treatment for an m1 stroke.A third-party access catheter was used and positioned in the low to mid cervical internal carotid artery (ica).A zoom 71 was advanced towards the m1 over a zoom 35- and third-party guidewire.The zoom 71 reached the m1 and was unable to advance further.Upon review the physician noticed the zoom 71 had prolapsed in the cervical internal carotid artery (ica).The physician attempted to retract the zoom 71 to straighten the catheter.During this attempt, the device became impinged against the third-party access catheter and separated.A snare was used to retrieve the distal segment of the zoom 71 successfully.The procedure was then completed using a new zoom 71 catheter.The patient was reported to be stable post procedure.

• 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: 23029505
• Report Number: 3014590708-2025-00019
• Device Sequence Number: 18520182
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: (01)00812212030450(17)280220(10)F2505001
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2505001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• 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: BMX 96.; SYNCHRO WIRE.; ZOOM 35.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female