MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI1240COM18
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that: "1.The first maneuver with the 1.5f flow directed catheter and hybrid008 was smooth.The second maneuver resulted in the hybrid getting stuck in the catheter.2.The optima coil complex 12x40 was pushed into the delivery catheter with an internal diameter of 0.017 inches.The coil then detached spontaneously.Fortunately, the coil can be retrieved with a snare." update 10jun2026 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? yes, the access through a vein and the target was a right cavernous sinus (indirect ccf case).However, on the left side, another coil brand was succesfully deployed.2.Will the microcatheter be available for return? no, we used the headway 17 microcatheter.3.Where did the implant prematurely detach? (inside the an, inside the mc? etc) the optima coil has just deployed two loops in the fistula, not the aneurysm.Then, we can't push the coil further due to it detaching itself (see attached image).4.Were any attempts made to detach the implant coil using the detachment controller? no.5.Can you confirm if the device was implanted? after the coil detached and broke down in the normal vessel, the doctor focused on taking out the coil, which was succesful using a snare".Incident report form submitted for this complaint indicates that no patient injury was sustained.

• 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: 25692094
• Report Number: 3014162263-2026-00072
• Device Sequence Number: 15815736
• Product Code: HCG
• UDI-Device Identifier: 00818053026485
• UDI-Public: (01)00818053026485(11)260410(17)310410(10)F260400506
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 07/02/2026

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: OPTI1240COM18
• Device Lot Number: F260400506
• 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: 06/05/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2026
• 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: Required Intervention; Other
• Patient Sex: Unknown