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

Model Number	ICTC088103R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A 73-year-old female patient was admitted for a bilateral middle meningeal artery (mma) embolization procedure.Access was obtained via right radial artery using a zoom rdl as a guide catheter.The rdl catheter was navigated smoothly to the right external carotid artery without issue.After successfully treating the right side, the rdl catheter was retracted and advanced across the aortic arch to the left common carotid and then up to the left external carotid.During this advancement, resistance was felt; however, the operators were not concerned about vasospasm.Successful treatment of the left mma was accomplished without any issues.Upon completion and final angiography, the physician attempted to remove the rdl.The catheter was retracted until the distal tip of the rdl was several centimeters above the right elbow.However, it could not be removed.Multiple attempts were made to remove the rdl without damaging the artery, including administering more vasodilators (verapamil), using a blood pressure cuff, and a transparent radial artery band; but the rdl would not release.The patient was transported to surgery for removal of the rdl.The orthopedic surgery team successfully removed the catheter and repaired the artery.The patient has fully recovered from the radial injury and was reported to be stable.No device issues were reported.
Additional Manufacturer Narrative
The device was discarded after use and therefore not available for return.Based on the reported information provide, the patient experienced vasospasm during retraction of the zoom rdl and was administered vasodilator drugs.It is unclear what may have contributed to the potential abnormal interaction with the device and radial artery.The manufacturing records for the zoom device were reviewed and demonstrated that the product met all the design and manufacturing specifications.

• Brand Name: ZOOM RDL RADIAL ACCESS SYSTEM
• Common Device Name: GUIDE CATHETER
• Manufacturer (Section D): IMPERATIVE CARE INC.; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE, INC.; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell avenue; campbell, CA 95008-6609
• MDR Report Key: 20173509
• Report Number: 3014590708-2024-00032
• Device Sequence Number: 12522753
• Product Code: DQY
• UDI-Device Identifier: 00812212030566
• UDI-Public: 00812212030566
• 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): 09/09/2024

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: 05/03/2025
• Device Model Number: ICTC088103R
• Device Catalogue Number: ICTC088103R
• Device Lot Number: F2412201
• 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: 08/14/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2024
• 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: 0.035" GLIDEWIRE; 0.038" GLIDEWIRE; APOLLO MICRO-CATHETERS; HYBRID WIRES; ZOOM 45; ZOOM 6F SIM INSERT CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 72 KG