MAUDE Adverse Event Report: RAPID MEDICAL LTD. COMANECI 17

Model Number	ANPP7199
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.Thrombus formation is a known potential complication associated with the use of coil embolization assist devices, including comaneci device.The ifu identifies thrombus as potential complications associated with use of the device.
Event or Problem Description
The following event was reported throughout the success post market surveillance study.A 58-year-old female with a history of hypertension, hyperlipidemia, hyponatremia, tobacco abuse disorder, and previous aneurysms, was treated with the comaneci 17 (l-mca aneurysm).Subject tolerated the procedure but shortly after developed right sided weakness, neglect, incomprehensible speech (nihss 20).Ct head w/o contrast negative for acute intracranial abnormalities.Subject was taken back to the ir suite for a cerebral angiogram which demonstrated distal occlusions, agrrastat was injected.S/p injection patient able to move right side, alert and oriented to person, able to speak and answer questions with some aphasia and dysarthria noted, she has facial droop (nihss 8).

• Brand Name: COMANECI 17
• Common Device Name: COMANECI 17
• Manufacturer (Section D): RAPID MEDICAL LTD.; po box 337; carmel biulding; yokneam, israel 20692 05; IS 2069205
• MDR Report Key: 16618081
• Report Number: 3015531723-2023-00006
• Device Sequence Number: 12285392
• Product Code: PUU
• UDI-Device Identifier: 07290015107150
• UDI-Public: (01)07290015107150(17)250228(10)220917CS01
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2023
• Report Date (Section F): 03/27/2023

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: 02/28/2025
• Device Model Number: ANPP7199
• Device Catalogue Number: ANPP7199
• Device Lot Number: 220917CS01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 58 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/27/2023