MAUDE Adverse Event Report: RAPID-MEDICAL LTD COMANECI PETIT

Model Number ANPP3188

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

Off-label use: in this event the comaneci was used to post dilate a stent.Stent post dilation is not part of the comaneci intended use.Per the instruction for use (ifu): the comaneci embolization assist device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width 10 mm.A wide-necked intracranial aneurysm defines the neck width as 4 mm or a dome-to-neck ratio < 2.

Event Description

Rapid medical was notified that during endovascular treatment with atlas stent of severe vasospasm the stent could not open.The physician decided to use the comaneci device outside of its intended use to post dilate the stent.As a result the stent dilated successfully, however, the comaneci device got stuck inside the stent and was left inside the patient.According to the physician the patient improved after the procedure.

• 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; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: orit yaniv ; carmel building, pob 337; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 10128360
• MDR Text Key: 194329152
• Report Number: 3009957947-2020-00003
• Device Sequence Number: 1
• Product Code: PUU
• UDI-Device Identifier: 07290015107044
• UDI-Public: (01)07290015107044(17)220331(10)191101CP02
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: ANPP3188
• Device Catalogue Number: ANPP3188
• Device Lot Number: 191101CP02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2020
• Was Device Evaluated by Manufacturer?: No
• 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