MAUDE Adverse Event Report: RAPID-MEDICAL LTD COMANECI 17; COMANECI EMBOLIZATION ASSISST DEVICE

Model Number	ANPP7199
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/29/2022
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.The patient was treated for right middle cerebral artery aneurysm coil embolization with the comaneci 17 as coil embolization assist device.While placing the embolization coil inside the aneurysm the physician noticed a thrombus forming within the comaneci stent.The physician stopped the coiling and removed the comaneci and the microcatheters from the patient's anatomy.A follow up contrast run still showed some slow filling of the distal right m3/m4 branches, therefore, a medication was administrated, and a follow up contrast run showed normal distal perfusion without evidence of distal thromboembolism.A neurological exam was performed 19 days post procedure, the patient was clinically asymptomatic and had no clinical sequelae, mrs score was 0.

• Brand Name: COMANECI 17
• Common Device Name: COMANECI EMBOLIZATION ASSISST DEVICE
• Manufacturer (Section D): RAPID-MEDICAL LTD; carmel building, p.o.b 337; yokneam, 20692 0520; IS 2069205206
• Manufacturer (Section G): RAPID MEDICAL LTD; carmel building, pob.337; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: orit yaniv ; carmel building, pob.337; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 16085192
• Report Number: 3009957947-2023-00001
• Device Sequence Number: 19337874
• Product Code: PUU
• UDI-Device Identifier: 07290015107150
• UDI-Public: (01)07290015107150(17)240531(10)211224CS01
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: DEN17064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2023

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: 05/31/2024
• Device Model Number: ANPP7199
• Device Catalogue Number: ANPP7199
• Device Lot Number: 211224CS01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male