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

Model Number	ANPP7199
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.Therefore, the root cause of the event cannot be determined.Coil protrusion is a known potential complication associated with the use of coil embolization assist devices, including comaneci.However, according to physician report, it is possible that the protruding of the subject device into the aneurysm, as it was being withdrawn, may have been associated to the patient's challenging acute basilar-pca angle.
Event or Problem Description
It was reported that during treatment of a wide-necked basilar tip aneurysm, the comaneci 17 was protruded into the aneurysm coil mass as it was being withdrawn.After multiple manipulations the physician withdrew the device and completed the aneurysm coiling procedure, however one coil remained herniated into the parent artery.There was no reported patient injury or clinical consequence.The patient is reported to be doing well.

• Brand Name: COMANECI
• Common Device Name: COMANECI 17
• Manufacturer (Section D): RAPID-MEDICAL LTD; carmel building, p.o. box 337,; yokneam, israel 20692 05; IS 2069205
• MDR Report Key: 12337259
• Report Number: 3009957947-2021-00006
• Device Sequence Number: 3937258
• Product Code: PUU
• UDI-Device Identifier: 07290015107150
• UDI-Public: (01)07290015107150(17)230731(10)210304CS01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: DEN170064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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: 07/31/2023
• Device Model Number: ANPP7199
• Device Catalogue Number: ANPP7199
• Device Lot Number: 210304CS01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2021
• Initial Report FDA Received Date: 08/18/2021
• 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