MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0413CSFMX
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
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: "the physician was treating a large opthalmic aneurysm with a primary coiling technique.We were roughly 4 coils into treatment when we tried to use a 4mmx13cm max coil.We did make a few adjustments of the coil to try to get it to sit properly.Upon the third adjustment, the coil kicked the micro out of the aneurysm.The physician pulled coil back and tried to advance micro back into aneurysm.While doing that---the coil pre-maturely detatched.We had to use several techniques to retrieve coil and coil was ultimately retrieved with a stentriever.There was moderate vessel tourtosity but the coil should absolutely be more durable that it was.The pre-mature detatched coil did end up traveling into the mca during retrievel attempts--because of this, the patient ended up having clot at the m1 bifurcation that was removed with a red 43 aspiration catheter." incident report form submitted for this complaint indicates that no patient injury was sustained.
Event or Problem Description
It was reported that: "the physician was treating a large opthalmic aneurysm with a primary coiling technique.We were roughly 4 coils into treatment when we tried to use a 4mmx13cm max coil.We did make a few adjustments of the coil to try to get it to sit properly.Upon the third adjustment, the coil kicked the micro out of the aneurysm.The physician pulled coil back and tried to advance micro back into aneurysm.While doing that---the coil pre-maturely detatched.We had to use several techniques to retrieve coil and coil was ultimately retrieved with a stentriever.There was moderate vessel tourtosity but the coil should absolutely be more durable that it was.The pre-mature detatched coil did end up traveling into the mca during retrievel attempts--because of this, the patient ended up having clot at the m1 bifurcation that was removed with a red 43 aspiration catheter.".
Additional Manufacturer Narrative
Balt usa reference: # (b)(4).An evaluation of the actual complaint sample could not be performed as the device was unavailable to be return.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 f250401176 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.Complaint feedback is tracked through our post market surveillance system and internal procedures.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: 24575688
• Report Number: 3014162263-2026-00009
• Device Sequence Number: 9435374
• Product Code: HCG
• UDI-Device Identifier: 00818053025129
• UDI-Public: (01)00818053025129(11)230802(17)280802(10)F250401176
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPTI0413CSFMX
• Device Lot Number: F250401176
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 02/09/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 06/22/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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; Other
• Patient Sex: Unknown