MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTIPAX3014
Medical Device Problem Codes	Failure to Advance (2524); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "mma embolization.Physician had a 6fr benchmark, plato 17 microcatheter, and a 0.014" wire.Frontal branch of right mma selected with distal access of plato 17.Physician began to deploy pax, felt some resistance while packing and then upon attempting to manipulate coil he felt the resistance gone and the coil was no longer attached.He pushed the rest of the coil out of the microcatheter wire a wire through the plato 17 and it was in mma and the imax." update 18mar2026 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? not unusually tortuous.2.Will the microcatheter be available for return? no 3.Where did the implant prematurely detach? (inside the an, inside the mc?, etc) about 10cm of the coil was in the anterior mma branch.The remaining 20cm was within the plato 17 microcatheter at time of premature detachment 4.Were any attempts made to detach the implant coil using the detachment controller? no 5.Can you confirm if the device was implanted? yes.It was pushed out with a wire and was partially in mma and imax arteries." 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 ; 9497881443
• MDR Report Key: 24716771
• Report Number: 3014162263-2026-00030
• Device Sequence Number: 20360841
• Product Code: HCG
• UDI-Device Identifier: 00840303713715
• UDI-Public: (01)00840303713715(11)251112(17)301112(10)F251100392
• 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
• 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): 06/09/2026

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: OPTIPAX3014
• Device Lot Number: F251100392
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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: Required Intervention
• Patient Sex: Unknown