MAUDE Adverse Event Report: RAPID MEDICAL LTD. COMANECI 17

Model Number ANPP7199

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/29/2022

Event Type  Injury  

Event 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.

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.

• Brand Name: COMANECI 17
• Type of Device: COMANECI 17
• Manufacturer (Section D): RAPID MEDICAL LTD.; po box 337; carmel building; yokneam, israel 20692 05; IS 2069205
• MDR Report Key: 16085542
• MDR Text Key: 306500585
• Report Number: 3015531723-2023-00001
• Device Sequence Number: 1
• Product Code: PUU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2023
• Distributor Facility Aware Date: 12/27/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male