MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0152CSSMX
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference: (b)(4) 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 records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f240801062 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.
Event or Problem Description
It was reported that: "the physician was doing a ruptured acom aneurysm coiling.He was using a 90cm ballast, a 6f sofia, with a plato microcatheter.He also had an eclipse ballon prepared and up around the ica terminus.The first coil in the aneurysm was a 1.5x2 optimax.The aneurysm was very small, measuring about 1.8x2.2.The plato catheter was very distal in the aneurysm, almost at the dome.The coil set up nicely, we tested the detachment and got a solid green.Went to deploy, and got the sound and appearance of a good detach.When pulling back, there was clear space between the edge of the microcatheter and the detachment zone.However, when pulling back harder the coil mass began to move.The physician was able to push back forward, but pushed the pusher wire through the dome of the aneurysm.Thankfully, there was no extravization due to there being coil presence and microcatheter taking up space.At this point, we went back to try another detach and we were able to pull the pusher wire back.There was no patient injury and we implanted one more coil after this." update 10oct2025 - additional information received from the issuer: "it was not very tortuous at all.Yes, the second attempt at detachment did detach the coil, however it may have just been from the forward pressure." update 30oct2025 - additional information received from the issuer: "the coil detached after being pushed back into the aneurysm using the pusher wire.After that, the physician was unsure whether or not the implant was detached and his continued forward pressure on the pusher wire ruptured the aneurysm.Unfortunately i do not have any images." 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: 23500830
• Report Number: 3014162263-2025-00092
• Device Sequence Number: 21080914
• Product Code: HCG
• UDI-Device Identifier: 00818053024955
• UDI-Public: (01)00818053024955(11)240823(17)290823(10)F240801062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/07/2025

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: OPTI0152CSSMX
• Device Lot Number: F240801062
• 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: 10/09/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2024
• 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