MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0517CSFMX
Medical Device Problem Codes	Stretched (1601); Optical Problem (3001); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference: # (b)(4).An evaluation of the actual complaint sample could not be performed as device was unavailable to be return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.Review of the lot history record for the reported lot was performed.Customer feedback has been noted for lot f231100323; however, there is no in-process issue that could account for the observation.This lot will remain subject to monitoring for any unacceptable increase in trend.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: " sex: unknown disease name: aneurysm (lesion site: a-com, lesion size: 6 mm) procedure: planned procedure, micro catheter: unknown, assist stent: unknown, y connector: unknown, used coils: unknown. in a case of an a-com aneurysm, the physician attempted coiling using the double catheter technique.After nearly completing framing with a target xl soft 6×20 coil, the physician proceeded to deploy an optimax 5×17 coil.During the procedure, the optimax 5×17 coil protruded from the neck of the aneurysm.When the physician attempted to retract the coil, the optimax 5×17 became stretched and could neither be advanced nor withdrawn.Subsequently, the optimax 5x17 coil was safely retrieved using a snare device.The procedure was then continued using an axium coil for framing and completed without further issues.There was vessel tortuosity near the c1 segment, and microcatheter control was difficult; however, no issues were observed when using other companies' coils.Pre-use check of the optimax 5×17 revealed no abnormalities." 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: 23646327
• Report Number: 3014162263-2025-00091
• Device Sequence Number: 14645107
• Product Code: HCG
• UDI-Device Identifier: 00818053025181
• UDI-Public: (01)00818053025181(11)231109(17)281109(10)F231100323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/26/2025

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: OPTI0517CSFMX
• Device Lot Number: F231100323
• 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: 10/31/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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: Required Intervention
• Patient Sex: Unknown