MAUDE Adverse Event Report: RAPID-MEDICAL LTD. COMANECI

Model Number ANPP7177

Device Problem Unintended Collision (1429)

Patient Problem Aneurysm (1708)

Event Date 01/27/2023

Event Type  Injury  

Event Description

It was reported that the comaneci was used as coil assist device to treat large rupture pcom aneurysm.After 3 coils had been deployed and detached , comaneci was attempted to be retrieved, however one loop was hooked in the comaneci mesh, and another coil was protruding and stretched from coli mass all of the way down into the groin.Several maneuvers were made with snare and solitaire device to remove the stretched coil from the patient, eventually, the coil was mostly removed.The procedure was completed by implementing additional coil, the aneurysm was packed.

Manufacturer Narrative

The device is not available to the manufacture.Coil entanglement is a potential, but rare complication associated with the use of the comaneci device.The labeling includes recommendation to verify the coil's stability in the aneurysm by deflating the device before coil detachment.

• Brand Name: COMANECI
• Type of Device: COMANECI
• Manufacturer (Section D): RAPID-MEDICAL LTD.; carmel bulding pob 337; yokneam, 20692 05; IS 2069205
• Manufacturer (Section G): RAPID-MEDICAL LTD.; carmel building pob337; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: orit yaniv ; carmel building pob337; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 16384861
• MDR Text Key: 309638320
• Report Number: 3009957947-2023-00003
• Device Sequence Number: 1
• Product Code: PUU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ANPP7177
• Device Catalogue Number: ANPP7177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention