MAUDE Adverse Event Report: RAPID-MEDICAL LTD COMANECI

Model Number ANPP7177

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

Patient Problem Aneurysm (1708)

Event Date 11/27/2019

Event Type  Injury  

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 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
• Type of Device: COMANECI
• Manufacturer (Section D): RAPID-MEDICAL LTD; carmel building, pob 337; yokneam, 20692 05; IS 2069205
• Manufacturer (Section G): RAPID-MEDICAL LTD; carmel building, pob 337; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: orit yaniv ; carmel building, pob 337; yokneam, israel 20692-05 ; IS 2069205
• MDR Report Key: 9636460
• MDR Text Key: 176649400
• Report Number: 3009957947-2020-00002
• Device Sequence Number: 1
• Product Code: PUU
• UDI-Device Identifier: 07290015107136
• UDI-Public: (01)07290015107136(17)211130(10)190616CC01
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2019
• 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): Disability
• Patient Age: 60 YR