MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0517CST10
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	04/16/2026
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 records did not reveal any in-process or lot-specific issue that could account for the observation.One additional complaint against lot number f251100786 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: "- during the process of push "5 x 17 cst" into aneurysm, the aneurysm was ruptured.- so, user attempted to form a frame with "5 x 17 cst" several times, the coil was detached.- according to the mention of assistant, the procedure was significantly delayed due to remove the coil.- the user considered, because the user tried frame procedure with some tension, the pre-detach came out.- the user did not complain so much at this time, but we have same issue already (3rd april), we are required to consider about pre-detach issue of 5x17cst which has same lot number and size." update 15jun2026 - additional information received from the issuer: "1.Would you be able to confirm if our understanding is correct: a.The physician was attempting to embolize the aneurysm and during the attempt to push the opti0517cst10 to the treatment location, they ruptured the aneurysm? no.2.The complaint description states "the procedure was significantly delayed due to remove the coil" how did the physician remove the coil? a.Where did the implant prematurely detach? (inside the aneurysm, or microcatheter, etc)- m/c.3.How would the tortuosity of the anatomy be described? n/a.4.What is the current patient status? discharged.".

• 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: 25692940
• Report Number: 3014162263-2026-00071
• Device Sequence Number: 15903693
• Product Code: HCG
• UDI-Device Identifier: 00818053026294
• UDI-Public: (01)00818053026294(11)251118(17)301118(10)F251100786
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: OPTI0517CST10
• Device Lot Number: F251100786
• 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: 06/03/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown