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 Thrombosis/Thrombus (4440)

Event Date 10/25/2019

Event Type  malfunction  

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.Notification of this incident was received from an automated notification system (ecrf) for the instant clinical study.The incident was reported by the clinical site to balt on 26sep2022 following a request by the clinical evaluation committee (cec) for the clinical site to add the event to the ecrf for the instant clinical study.Reported information concluded patient harm had possible relation to optima 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 formation of thrombus.Reported information concluded patient harm was not related 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 was reported to have resulted in "in-patient hospitalization or prolongation of existing hospitalization".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.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: "event description: mass effect with presence of minimass clotting.Seriousness: resulted in in-patient hospitalization or prolongation of existing hospitalization.Relationship to optima coils system: possible.Relationship to procedure: not related.Action: medication.Event status: resolved.Date of event resolution: (b)(6) 2019." on 28sep2022 - additional information provided from the issuer: the source document from the clinical site indicated that the patient benefited from the embolization of the aneurysm of the right anterior cerebral artery with the placement of 14 coils.During the procedure, blood flow was reduced at the level of the right anterior cerebral artery.Alteplase was performed, allowing recovery of flow with a satisfactory parenchymogram at the end of the procedure.Platelet anti aggregation was introduced at the request of the neurologists.Preventive anticoagulation (lovenox) was administered during the procedure.Following the embolization procedure, medications were lifted allowing extubation of the patient.

• 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: 15579984
• MDR Text Key: 307263344
• Report Number: 3014162263-2022-00034
• Device Sequence Number: 1
• Product Code: HCG
• 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: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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: 09/26/2022
• 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): Required Intervention