MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI2065COM18
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
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.No additional complaints against lot number f251100937 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 a coil embolization of a spinal avm, the physician attempted to deploy an optima complex-18 (20 × 65) as the seventh coil through a headway 27 microcatheter.During deployment, while attempting to reposition, he reported feeling a "pop" and subsequently lost one-to-one control of the coil.Multiple attempts were made using different guidewires and coil pushers to advance the remaining portion of the coil out of the microcatheter; however, these attempts were unsuccessful.The coil was ultimately unintentionally snared by a coil pusher within the microcatheter, and the physician was able to successfully remove both the coil and microcatheter.After re-accessing with a headway duo 156 cm microcatheter, the physician proceeded with additional coil deployment.During placement of an optimax soft (16 × 50), he again experienced loss of one-to-one control, and the coil was prematurely detached with greater than 50% of the coil remaining within the microcatheter.Attempts to advance the coil using guidewires were unsuccessful.A syringe was then attached to the hub, and negative pressure was applied while withdrawing the microcatheter, resulting in successful removal of the entire coil.Both coils were prepared per the instructions for use (ifu).No patient injury occurred.The products are not available for return." 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: 24905277
• Report Number: 3014162263-2026-00037
• Device Sequence Number: 9085584
• Product Code: HCG
• UDI-Device Identifier: 00818053026546
• UDI-Public: (01)00818053026546(11)230811(17)280811(10)F251100937
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/16/2026

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: OPTI2065COM18
• Device Lot Number: F251100937
• 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: 03/20/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2023
• 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