MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI3520BLK
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
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 f240801044 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 or Problem Description
It was reported that: "vein of galen embolization on infant - multiple optiblocks utilized but various sizes weren't forming due to flow.Physician put the 3.5x20 on the back table along with other coils in the loop.Once he got the first coil to form, he put the 3.5x20 block back into the patient and went to pull back to reposition and it broke off.The location was okay and physician just pushed remaining coil out since it prematurely detached." incident report form submitted for this complaint indicates that no patient injury was sustained.Additional information received from issuer 05may2025: "the anatomy was fairly tortuous as it was a high flow vein of galen and the doctor was treating splenial 2.He was in the splenial 2 which was a pedacle of the vogn.He advanced the coil forward and didn't love the way it was forming so he pulled it back and that's when it detached.No attempts made to detach with controller.Device was implanted in patient.No harm was done it was in the location he wanted just didn't form the way he had hoped.".

• 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: 22118018
• Report Number: 3014162263-2025-00028
• Device Sequence Number: 7157501
• Product Code: HCG
• UDI-Device Identifier: 00810068568967
• UDI-Public: (01)00810068568967(11)240823(17)290823(10)F240801044
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/30/2025

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: OPTI3520BLK
• Device Lot Number: F240801044
• 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: 04/30/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2024
• 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