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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A female patient was admitted for a bilateral middle meningeal artery (mma) embolization procedure.Access was obtained via the right radial artery using a zoom 88 support guide catheter.The right-side embolization was completed successfully with no issues.However, while attempting to track the catheter through the aortic arch over to the left common carotid artery, significant resistance was felt.The zoom 88 support guide catheter was removed, and a zoom rdl was introduced using the rdl dilator over 0.035" glidewire advantage and a non-disclosed third party select catheter.Upon attempting to advance the zoom rdl into the arch anatomy, resistance was again felt.The treating physician attempted to remove the rdl but was unsuccessful.It was confirmed that vasospasm occurred, and the radial artery clamped down on the shaft of the rdl at approximately 3-4 cm from the radial access site.Vasodilator medications were administered at the beginning of the case as well as to relieve the vasospasm.After several unsuccessful attempts to remove the catheter, the treating physician called in for surgical support.Meanwhile, the physician used femoral access and successfully completed the left mma embolization procedure without any issues.Immediately following the mma embolization and while still in the angio suite, the orthopedic surgery team successfully removed the catheter and repaired the artery.The patient was released the next day with a full recovery from both the radial injury and a successful mma embolization.
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: 19743044
• Report Number: 3014590708-2024-00025
• Device Sequence Number: 11684927
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

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: 02/06/2025
• Device Model Number: ICTC088103R
• Device Catalogue Number: ICTC088103R
• Device Lot Number: F2402202
• 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: 06/19/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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: GLIDEWIRE ADVANTAGE; SIM 2 SELECT CATHETER; ZOOM 88 SUPPORT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female