MAUDE Adverse Event Report: RAPID-MEDICAL LTD COMANECI

Model Number	ANPP7177
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: the device has not been returned for evaluation, however, device history record (dhr) review confirmed that the device met all material assembly and performance specifications.In addition, the provided information indicates that the device operated as expected and the event is not associated to device manufacturing or design issues.Coils entanglement is a known potential complication associated with the use of the comaneci and other coils embolization assist devices , the instruction for use (ifu) contains recommendation to verify the coil's stability in the aneurysm by deflating the device before coil detachment in order to prevent coils entanglement.The root cause cannot be conclusively determined; however, according to physician report, it is possible that the aneurysm square structure and aneurysms size (height of 4mm, neck of 3.5mm and width of 3.5mm) may have contributed to the reported event.Based on the above, it is possible that procedural and handling factors may have contributed to the reported event.Corrected data: this report was late due to the webtrade enrollment process, the company purchased digital certificate from comsign as recommended at https://www.Fda.Gov/industry/about-esg/esg-appendix-c-digital-certificates), the comsign certificate that the company bought was approved for the registration of rapid medical webtrader account, however, once the company tried to submit the demo mdr, it was found out that comsign service cannot provide.P12 private key as required.Therefore, the company need to contact anther digital certificate supplier (out of israel) that is able to provide the required certificate.
Event or Problem Description
Rapid medical received report that coils got tangled in the comaneci embolization assist device.This event occurred during a comaneci assisted coiling of a right ophthalmic aneurysm.The comaneci performed as intended, however, coils got tangled in the device.The physician attempted several times to release the tangled coils by opening and closing device mesh without success.Therefore, lvis stent was deployed distal to the comaneci, once the lvis stent was placed, the physician closed the comaneci mesh and the herniated coils end were pressed against the vessel wall.The procedure was successfully completed without any further issues.The physician recognized it was a technical error.The patient did not experience any adverse effects due to this occurrence.

• Brand Name: COMANECI
• Common Device Name: COMANECI
• Manufacturer (Section D): RAPID-MEDICAL LTD; carmel building, pob 337; yokneam, 20692 05; IS 2069205
• MDR Report Key: 9636460
• Report Number: 3009957947-2020-00002
• Device Sequence Number: 2913098
• Product Code: PUU
• UDI-Device Identifier: 07290015107136
• UDI-Public: (01)07290015107136(17)211130(10)190616CC01
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

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: 11/30/2021
• Device Model Number: ANPP7177
• Device Catalogue Number: ANPP7177
• Device Lot Number: 190616CC01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 01/28/2020
• 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
• Patient Age: 60 YR