MAUDE Adverse Event Report: Balt USA Optima Coil System

Model Number	OPTI4510CSF10
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "the physician planned to treat acom aneurysm and primed the vasco 10 micro catheter after prechecked the optima complex 4.5x10 coil he placed it inside the aneurysm and tried to detach the coil.After multiple attempts and tried all the techniques the coil didn't detach so he tried to resheath the coil into the micro catheter the coil got detached halfway into the fargo guiding catheter.The physician removed the coil by aspirating and used another optima to finish the procedure." update 29jun2026 - additional information received from the issuer: "1.The vessel was torturous.2.The detacher, micro catheter is not available for return.3.Precheck was performed on the coil.4.The xcel showed red and green light when the physician was ready to detach.We tried rotating the xcel, wiping the detachment gold marker end, still red and green light was blinking." 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: 50015103
• Report Number: 3014162263-2026-00077
• Device Sequence Number: 9572862
• Product Code: HCG
• UDI-Device Identifier: 00818053026133
• UDI-Public: (01)00818053026133(11)250212(17)300212(10)F250200387
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 08/25/2026

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: OPTI4510CSF10
• Device Lot Number: F250200387
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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