MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM RDL RADIAL ACCESS SYSTEM

Model Number	ICTC088103R
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A zoom rdl was returned for investigation.Visual inspection found the marker band was deformed and the tip opening was ovalized.Per the customer, the zoom rdl was examined upon removal from the patient and tip damage was not observed at that time.It is not known if the tip damage occurred during the procedure or during handling and transport of the zoom rdl back to imperative care.As noted from the reported complaint, there was no device malfunction reported.Therefore, the damaged tip was not considered to be related to the reported adverse event.Based on the investigation a root cause for the artery damage could not be determined.However, two potential contributing factors to the complaint were identified.First, was the noted usage of the zoom rdl in vasculature with an id too small for the od of the catheter.The zoom rdl ifu states, "prior to use, ensure that the dimensions (e.G., diameter and length) of the zoom rdl radial access system and accessory/adjunctive devices to be used in the procedure are compatible with each other and appropriate for the target vasculature." the second potential factor was the delay in removal of the zoom rdl due to the preparation and application of the tr band agitating the vessel leading to the artery damage.The manufacturing records for the zoom rdl were reviewed and demonstrated that the product met all the design and manufacturing specifications.
Event or Problem Description
A female patient was admitted for an embolization of an internal carotid artery (ica) aneurysm with web intrasaccular device.Right ica access was obtained via the right radial artery using a zoom rdl.The case was completed successfully with no issues related to the access and the zoom rdl.The zoom rdl was retracted into the radial artery but had to wait 2-3 minutes for the team to obtain and prep a tr band (radial closure device).After placement of the tr band, the physician continued to remove the zoom rdl but felt resistance.He pulled through the resistance.Upon removal, a segment of the radial artery was noted on the catheter shaft.There was no bleeding at the site and no evidence of a hematoma forming.The patient was taken to the angio suite to perform hand ligation.The artery had been damaged approximately 5 cm proximal to the radial access site.The patient made a full recovery with full function of the hand.The physician noted that the estimated inner diameter (id) of the radial artery was likely too small for the outside diameter (od) of the zoom rdl.Additionally, it was noted prior to removal of the zoom rdl that there was a delay to prep and apply a tr band.It is suspected that this delay led to agitation of the vessel resulting it to constrict/spasm, forcing the injury.There was no device malfunctions reported.

• Brand Name: ZOOM RDL RADIAL ACCESS SYSTEM
• Common Device Name: ZOOM RDL RADIAL ACCESS SYSTEM
• 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 85008-6609 ; 4082029060
• MDR Report Key: 21229458
• Report Number: 3014590708-2025-00001
• Device Sequence Number: 12833425
• Product Code: DQY
• UDI-Device Identifier: 00812212030566
• UDI-Public: (01)00812212030566(17)250722(10)F2419401
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K220807
• 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): 01/24/2025

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: 07/22/2025
• Device Model Number: ICTC088103R
• Device Catalogue Number: ICTC088103R
• Device Lot Number: F2419401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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: 0.038" GLIDEWIRE; ZOOM 6F SIM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female