MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0827CSF10
Medical Device Problem Codes	Stretched (1601); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician, while treating an a-com aneurysm, planned to treat by standard coiling.Took access to the location with ballast 90 long sheath and navien distal access catheter , physician took access to aneurysm with sl 10 micro-catheter and traxcess micro wire , removed the wire after accessing inside to the aneurysm and successfully placed the micro catheter inside the aneurysm , tool optima 8mm 27 soft complex as the first coil.Prechecked the coil and gave a green signal , started cooling and when tried to detach the xcel controller gave a green signal of successful detachment , but the coil wasn't detached and even after after multiple attempts with different detachers it wasn't detaching.Physician decided to took it back.While retrieving the coil got stretched and detached and physician had to catch it back with a catchmini stent retriever.Resumed cooling with different sizes and case finished successfully and patient extubated and doing fine with medications on".Incident report form submitted for this complaint indicates that no patient injury was sustained.
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.

• 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: 24701082
• Report Number: 3014162263-2026-00028
• Device Sequence Number: 10439723
• Product Code: HCG
• UDI-Device Identifier: 00818053026232
• UDI-Public: (01)00818053026232(11)250725(17)300725(10)F250700998
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 06/18/2026

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: OPTI0827CSF10
• Device Lot Number: F250700998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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