MAUDE Adverse Event Report: Balt USA Optima Coil System

Model Number	OPTI0212BLK
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: " during a coil embolization of bi-lateral mma for csdh, the physician attempted to deploy his last coil an optiblock 2x12 coil through a sl-10 microcatheter.As he advanced the coil he attempted to reposition and lost 1 to 1 and it was observed that the coil was no longer attached to delivery wire.He attempted to use delivery wire and a synchro wire to push the remainder of the coil out of sl-10.This was noted to be difficult and he had to leave a long coil tail into the maxillary.Coil was prepped per dfu.No patient injury occurred." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference: #(b)(4).Investigation pending return of suspected device.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 ; +1(949)788-1443
• MDR Report Key: 50476904
• Report Number: 3014162263-2026-00086
• Device Sequence Number: 15975953
• Product Code: HCG
• UDI-Device Identifier: 00840303712435
• UDI-Public: (01)00840303712435(11)260421(17)310421(10)F260401038
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/27/2026

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: OPTI0212BLK
• Device Lot Number: F260401038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2026
• 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; Required Intervention
• Patient Sex: Unknown