MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0306CSS10
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician was treating a pcom aneurysm case.After successfully deploying few coils from headway 17,.He took this 3*6 optima coil and place it inside the y connector and waited for saline to come out of the sheath, once the droplets come out from the sheath, then he start deploying the coil inside the aneurysm and after succeful deployment he detached the coil ad remove the pusher wire from the micro catheter and took a flouro run that time he founds there is something lying near the neck of the aneurysm after taking few more shots he realized that it is the part of the detached pusher wire then he had to deploy a stent over it and completed the case." 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.
Additional Manufacturer Narrative
Balt usa reference (b)(4).The returned device was inspected in our quality laboratory.During our analysis: - we observed only the introducer sheath was included with the device return.- we noted that the in-house coil was able to advance from the returned introducer sheath with no resistance.- we observed the delivery pusher and implant coil were not returned.- we observed no visual damage to the returned introducer sheath.Root cause of the introduction issues could not be determined due to the incomplete device return.During our evaluation, we observed only the introducer sheath was included with the device return.Without the return of the coil system used during the event, further testing in order to replicate the reported issue could not be performed.Review of the manufacturing indicates that the unit passed final inspection of the coil system, which indicates that coil system was free from damage at the point of final inspection.Review of the lot history record for the reported lot was performed.No additional complaint with lot number f240501449 was filed in conjunction with this report; however, there is no in-process or lot-specific issue that could account for the observation.This lot will remain 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 treating a pcom aneurysm case.After successfully deploying few coils from headway 17, he took this 3*6 optima coil and place it inside the y connector and waited for saline to come out of the sheath, once the droplets come out from the sheath, then he start deploying the coil inside the aneurysm and after succeful deployment he detached the coil ad remove the pusher wire from the micro catheter and took a flouro run that time he founds there is something lying near the neck of the aneurysm after taking few more shots he realized that it is the part of the detached pusher wire then he had to deploy a stent over it and completed the case." 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: 21230679
• Report Number: 3014162263-2024-00111
• Device Sequence Number: 7541667
• Product Code: HCG
• UDI-Device Identifier: 00818053025884
• UDI-Public: (01)00818053025884(11)240530(17)290530(10)F240501449
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/11/2025

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: OPTI0306CSS10
• Device Lot Number: F240501449
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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: Required Intervention
• Patient Sex: Unknown