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

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent mechanical thrombectomy for the removal of clot in the middle cerebral artery (mca) and anterior cerebral artery (aca).During the first pass, the zoom 71 catheter broke at the distal end.A new zoom 71 catheter was utilized with a third-party device to continue the procedure for removal of clot.During the third pass, the second zoom 71 catheter along with the third-party device was used to retrieve the dislodged portion of the initial zoom 71 catheter.Subsequently, two additional passes were performed in the aca with zoom 45 catheter to complete the procedure.Additional information indicated that the patient's anatomy was tortuous due to a loop in the distal internal carotid artery (ica) and resistance was encountered during retraction of the zoom 71.Post procedure, the patient experienced arterial spasm possibly related to history of drug use.
Additional Manufacturer Narrative
The zoom 71 distal segment was returned for investigation.It was confirmed that a shaft break had occurred.The investigation noted damage on the zoom 71 consistent with an axial force being applied, resulting in stretching of shaft materials prior to the device breaking.Additionally, kink and tip damage were observed on the distal segment.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.Based on the complaint information, the exact root cause for the complaint could not be determined.Likely factors that contributed to the reported complaint were a tortuous anatomy in the form of a loop in the internal carotid artery and retraction of the zoom 71 against resistance while inside a third-party access catheter.The zoom 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.

• 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: 22889998
• Report Number: 3014590708-2025-00018
• Device Sequence Number: 18372375
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: (01)00812212030450(17)270604(10)F2414503
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2414503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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: ABBOTT ROTATING HEMOSTATIC VALVE (RHV); ARISTOTLE .024" WIRE; BALLAST ACCESS CATHETER; PHENOM .027 CATHETER; TREVO STENT RETRIEVER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White