MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0103BLK
Medical Device Problem Codes	Separation Failure (2547); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician was treating an avm that was being fed from the left mma.We had already deployed two optiblock mini coils with no issues and were hoping to finish the case with an optiblock.We were in the posterior branch of the mma and the physician wanted to deploy the optiblock 1x3 very distal.When going to detach the coil, he saw daylight and had forward pressure on the coil.He tested the coil in the detacher and got a solid green, then went through all normal coiling and detachment procedure.After pressing the button and getting the sound of a good detachment, he pulled back on the pusher and thought the coil was detached.After pulling back about 1cm, he realized it was indeed not detached.He tried to advance his pusher wire and microcatheter, there was clear gap between pusher and coil.He then pulled back on his micro and noticed that he was pulling back coil mass as well with his micro.He advanced his traxcess wire to clear the tip of the micro and pushed the remaining coil mass back.The coil mass had still migrated about 4cm back but was still in a clinically safe location.There was no patient injury involved, and we concluded the case." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference: #(b)(4) an evaluation of the actual complaint sample could not be performed as device was unavailable to be return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.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 f240200437 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.

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 22828395
• Report Number: 3014162263-2025-00069
• Device Sequence Number: 9566977
• Product Code: HCG
• UDI-Device Identifier: 00810068568851
• UDI-Public: (01)00810068568851(11)240216(17)290216(10)F240200437
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPTI0103BLK
• Device Lot Number: F240200437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown