MAUDE Adverse Event Report: RAPID-MEDICAL LTD. COMANECI PETIT

Catalog Number ANPP3188

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

Patient Problem Aneurysm (1708)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer narrative: according to the physician the device was operated as expected, attempts were made to obtain specific procedure information, however no further details were provided 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 needed to contact anther digital certificate supplier (out of (b)(4)) that is able to provide the required certificate.

Event Description

Rapid-medical received information regarding comaneci petit device being left inside the patient.No specific details were given regarding the cause of the event or the attempts to retrieve the device.The physician claimed it is not due to a malfunction of the device and decided to leave device within the patient, the patient did not worsen as a result of this event, no further surgical intervention is planned, the patient is on anti-platelets therapy.Attempts were made to obtain specific procedure and device information; however, the attempts were unsuccessful.This case was performed out of us.

• Brand Name: COMANECI PETIT
• Type of Device: COMANECI PETIT
• 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; 20692 05; IS 2069205
• Manufacturer Contact: orit yaniv ; carmel building, pob 337; yokneam, israel 20692-05 ; IS 2069205
• MDR Report Key: 9636167
• MDR Text Key: 177378645
• Report Number: 3009957947-2020-00001
• Device Sequence Number: 1
• Product Code: PUU
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: DEN170064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare 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 Catalogue Number: ANPP3188
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 01/28/2020
• 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): Disability
• Patient Age: 50 YR