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 Aneurysm (1708)

Event Date 12/14/2022

Event Type  Injury  

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 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
• Type of Device: COMANECI 17
• Manufacturer (Section D): RAPID MEDICAL LTD.; po box 337; carmel biulding; yokneam, israel 20692 05; IS 2069205
• MDR Report Key: 16618081
• MDR Text Key: 312023425
• Report Number: 3015531723-2023-00006
• Device Sequence Number: 1
• Product Code: PUU
• UDI-Device Identifier: 07290015107150
• UDI-Public: (01)07290015107150(17)250228(10)220917CS01
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• 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: 220917CS01
• 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: 03/27/2023
• Distributor Facility Aware Date: 03/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Sex: Female