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

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoom 71 was returned with separated distal and proximal catheter segments held together by a strand of catheter shaft material.Device investigation noted damage which suggests an axial force was applied during the procedure, resulting in stretching of shaft materials prior to the device breaking.It was also noted the distal segment had a crushed distal tip.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.The zoom 71 shaft break occurred outside the patient when attempting to remove it from the zoom support catheter post use.The root cause of the observed damage on the zoom 71 causing the difficulty in removing it from the zoom support could not be determined from the device investigation leading to the shaft break.
Event or Problem Description
A zoom 71 was utilized to treat an occlusion at the m1 segment.Initial angiogram appears to show some narrowing in the internal carotid artery (cause unknown).The patient had no stenosis or significant calcifications; however, the anatomy was tortuous with a bovine arch and 90°angle just above the carotid bulb.Access obtained with zoom 88 support which was parked low in the internal carotid artery (ica).Zoom 71 was delivered over a third-party micro catheter and third-party guidewire to the m1 clot through the zoom 88 support with no resistance.Aspiration was performed with the zoom 71.While retracting the zoom 71 into the zoom 88 support, the physician felt resistance.He stopped and removed the zoom 71 and zoom 88 supports as a system from the patient.Outside the patient the doctor attempted to pull with force to remove the zoom 71 from the zoom 88 support.The zoom 71 broke outside of the patient approximately 10cm from the distal tip.No kinks or damage were observed on the access catheter, guidewire, or microcatheter.The case was completed with a third-party aspiration catheter and stent.There was no patient sequelae reported.

• 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: joy patel ; 1359 dell ave; campbell, CA 95008-6609 ; 4082029060
• MDR Report Key: 21861325
• Report Number: 3014590708-2025-00008
• Device Sequence Number: 20016662
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: (01)00812212030450(17)271202(10)F2433201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211476
• 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): 04/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2433201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Date Device Manufactured: 12/02/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNCHRO SELECT WIRE; TREVO TRACK 21; ZOOM 88 SUPPORT
• Patient Sex: Unknown