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

Model Number ANPP7199

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/30/2021

Event Type  Injury  

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to physician report, it is possible that the protruding of the subject device into the aneurysm, as it was being withdrawn, may have been associated to the patient's challenging acute basilar-pca angle.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 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of a wide-necked basilar tip aneurysm, the comaneci 17 was protruded into the aneurysm coil mass as it was being withdrawn.After multiple manipulations the physician withdrew the device and completed the aneurysm coiling procedure, however one coil remained herniated into the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
• Type of Device: COMANECI 17
• Manufacturer (Section D): RAPID-MEDICAL LTD; carmel building, p.o. box 337,; yokneam, israel 20692 05; IS 2069205
• Manufacturer (Section G): RAPID-MEDICAL LTD; carmel building, p.o. box 337; yokneam, israel 20692 05; IS 2069205
• Manufacturer Contact: orit yaniv ; carmel building, p.o. box 337; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 12337259
• MDR Text Key: 267213361
• Report Number: 3009957947-2021-00006
• Device Sequence Number: 1
• Product Code: PUU
• UDI-Device Identifier: 07290015107150
• UDI-Public: (01)07290015107150(17)230731(10)210304CS01
• 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: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/31/2021
• Initial Date FDA Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability