MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0308CSS10
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician planned to do a pcom aneurysm case.The plan was to use optima coils.After getting access to the aneurysm took optima complex soft 4x13and followed with optima complex ss 3x8.The physician packing the optima complex ss 3x8 coil and somemovent coil no movement prematurely detached and coil migrated to the ica bifurcation.The physician trying to out premature coil but he facing some difficulties and after that the physician used stentretriver and removed the coil.The physician took another optima coil finished the case.The case went off well and the patient is doing fine." incident report form submitted for this complaint indicates that no patient injury was sustained.Update 22apr2025- additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? no 2.Will the microcatheter be available for return? no 3.Where did the implant prematurely detach? (inside the an, inside the mc?, etc) partially deployed in the coil aneurysm and one loop came out and physician trying to pull back no movement.4.Were any attempts made to detach the implant coil using the detachment controller? no 5.Can you confirm if the device was implanted? the coil moved to parent artery after that removed the coil with the stent retriever.".
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 implant coil was included with the device return.- we observed the delivery pusher and introducer sheath was not return.- we observed multiple minor and major kinks along the implant coil.- we observed the returned implant coil is severely covered in dried blood.- we noted the associated microcatheter was not included in the device return.Root cause of the reported issue endured by the coil system cannot definitively be determined due to the incomplete device return.Upon return of the device, we noted only the implant coil was returned for analysis without the associated delivery pusher.We observed multiple minor and major kinks along the implant coil, however the exact timing of when this damaged occurred is unknown.Further analysis of the coil system was unable to be performed due to the lack of return of the delivery pusher.If the delivery pusher had become damaged, this could have further contributed to the issues encountered by the user, however this could not be confirmed.Review of the manufacturing records indicate 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 records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaint against lot number f250100144 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 planned to do a pcom aneurysm case.The plan was to use optima coils.After getting access to the aneurysm took optima complex soft 4x13 and followed with optima complex ss 3x8.The physician packing the optima complex ss 3x8 coil and somemovent coil no movement prematurely detached and coil migrated to the ica bifurcation.The physician trying to out premature coil but he is facing some difficulties and after that the physician used stentretriver and removed the coil.The physician took another optima coil finished the case.The case went off well and the patient is doing fine." incident report form submitted for this complaint indicates that no patient injury was sustained.Update 22apr2025- additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? no.2.Will the microcatheter be available for return? no.3.Where did the implant prematurely detach? (inside the an, inside the mc? etc) partially deployed in the coil aneurysm and one loop came out and physician trying to pull back no movement.4.Were any attempts made to detach the implant coil using the detachment controller? no.5.Can you confirm if the device was implanted? the coil moved to parent artery after that removed the coil with the stent retriever.".

• 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: 22038663
• Report Number: 3014162263-2025-00023
• Device Sequence Number: 8142061
• Product Code: HCG
• UDI-Device Identifier: 00818053025891
• UDI-Public: (01)00818053025891(11)250107(17)300107(10)F250100144
• 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): 06/27/2025

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: OPTI0308CSS10
• Device Lot Number: F250100144
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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