MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number NOT REPORTED

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

Patient Problem Thromboembolism (2654)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

Balt usa reference number: #(b)(4).An evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Incident was reported via following an internal clinical audit being performed by a independent third-party while conducting review of the active clinical study database on 16nov2021.Reported information concluded patient harm had possible relation to device.Lack of device return prevented deeper evaluation of the device as a potential root cause.Review of prior testing and existing post market data has not established any known causal relationship between the device and thrombus formation.Reported information concluded patient harm had causal relation to the procedure.Ischemia (including thrombus/emboli/clot) is a known risk inherent to embolic coiling procedures, as evidenced in the optima coil risk management and instructions for use.The incident resulted in medical or surgical intervention to prevent life threatening illness.It was reported that medication was administered and the harm status was resolved later the same day.The lot number was not provided therefore; a review of the lot history records could not be performed.Based on the provided information, root cause is likely attributable to procedural complication but could not be definitively determined.

Event Description

It was reported that: "event description: thrombus formation during coiling.Seriousness: resulted in medical or surgical intervention to prevent life threatening illness.Relationship to optima coils system: possible.Relationship to procedure: causal relationship.Action: medication.Event status: resolved.Date of event resolution: (b)(6) 2019".

• 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: 12849400
• MDR Text Key: 281072065
• Report Number: 3014162263-2021-00040
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K200030
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT REPORTED
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention