MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0410CSS10
Medical Device Problem Codes	Stretched (1601); Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during the endovascular embolization procedure, an attempt was made to implant the optima complex microcoil (4 mm x 10 cm) at the target site.After placement and activation of the delivery wire, a failure in mechanical expansion was observed.The coil did not assume the expected spatial conformation (loop formation), remaining linear or insufficiently expanded within the microcatheter/vessel.Due to the risk of migration or inadequate occlusion due to lack of anchorage, the device was completely removed from the patient.A new (spare) unit with identical specifications was requested to continue the procedure.The replacement allowed the embolization to be successfully completed without clinical harm to the patient." 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: 24968082
• Report Number: 3014162263-2026-00038
• Device Sequence Number: 18766017
• Product Code: HCG
• UDI-Device Identifier: 00818053025952
• UDI-Public: (01)00818053025952(11)230829(17)280829(10)F230800849
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/23/2026

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: OPTI0410CSS10
• Device Lot Number: F230800849
• 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: 03/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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