MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0208CSS10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician was treating an avm on a 3.5-year-old patient.He treated the feeding vessel with 3 optiblock mini coils and had a great result.He performs research and takes a coil and moves it around in the area of the avm so he can take the cells and do testing for research.Unfortunately, while he was allowing the coil to move inside the avm, the coil detached.Physician understands it may be due to the stress that was put on the coil.He was able to snare the coil and did not cause any negative harm to patient and was able to resume case successfully.Used a headway duo 167 micro." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference: #(b)(4).The returned device was inspected in our quality laboratory.During our analysis: - we observed only the implant coil was included with the device return.- we observed the delivery pusher and introducer sheath was not returned.- we observed multiple major kinks and stretching along the implant coil.- we noted the associated microcatheter was not included in the device return.Root cause of the reported issue endured by the coil system cannot definitively be determined due to the incomplete device return.Upon return of the device, we observed only the implant coil was returned for analysis without the associated delivery pusher and introducer sheath.We observed multiple minor kinks along the implant coil in addition to stretching, however the exact timing of when this damaged occurred is unknown.Based on the complaint description, it was indicated that "physician understands it may be due to the stress that was put on the coil".Without the return of the delivery pusher used during the event, further evaluation of the internal sr thread could not be performed to confirm the characteristics of the thread.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f250100514 has been made for the same issue.Comprehensive analysis of this failure mode has remained 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.

• 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: 25174428
• Report Number: 3014162263-2026-00051
• Device Sequence Number: 13403538
• Product Code: HCG
• UDI-Device Identifier: 00818053025815
• UDI-Public: (01)00818053025815(11)250115(17)300115(10)F250100514
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 05/14/2026

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: OPTI0208CSS10
• Device Lot Number: F250100514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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