MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0102HSS10

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

Balt usa reference#: (b)(4).An evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Notification of incident received from automated sender for notification of incident.Clinical project manager provided the following justification as to why there was a delay between incident date and the date balt usa was notified: "about the reporting delay its a mistake from the physician, a reminder was done regarding the reporting timelines." the incident resulted in medical or surgical intervention to prevent life threatening illness.It was reported that medication was administered and the harm has since been resolved.The type of device deficiency was reported to be "a user error", but this could not be definitively determined.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number 062819a has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.

Event Description

It was reported that: " ·date of deficiency: (b)(6) 2020 · description of deficiency: coil protrusion at the level aneurysm's neck and mca inferior branch, worsening after detachment.Due to proximal and distal clotting in the inferior branch, tirofiban was injected and good patency obtained.· device serial or lot number: (b)(4).· type of device deficiency: a user error · did the deficiency lead to death or serious deterioration in health of the patient? no · did the deficiency lead to death or serious deterioration in health of the user or another person? no · could the deficiency have led to death or serious deterioration in health of the patient, the user or another person if the circumstances had been less fortunate or in the absence of the intervention of healthcare personnel? yes".

• Brand Name: OPTIMA COIL SYSTEM
• Type of Device: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 13078540
• MDR Text Key: 285355777
• Report Number: 3014162263-2021-00045
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053022098
• UDI-Public: 00818053022098
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: OPTI0102HSS10
• Device Catalogue Number: N/A
• Device Lot Number: 062819A-073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2019
• 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): Required Intervention