MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0923CST10
Medical Device Problem Codes	Failure to Advance (2524); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference # (b)(4).On 28jul2025: additional information was received from the issuer regarding this incident.Therefore, an updated reportability evaluation was documented which determined this incident should be upgraded to reportable based on the additional information received.The returned device was inspected in our quality laboratory.During our analysis: - we observed only the introducer sheath was included with the device returned; - we observed the coil system and implant coil was not return; - we observed no visual damage to the returned introducer sheath; - we noted that an in-house coil was able to advance from the returned introducer sheath with no resistance.Root cause of the reported advancement 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 of the premature detachment encountered by the user could not be performed.The returned introducer sheath was tested with an in-house coil system, which revealed the in-house coil system was able to advance completely through the returned sheath with no resistance.Review of the manufacturing records indicate 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 records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaint against lot number f220900886 have 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: "when positioning the first microcoil in the aneurysm, the doctor noticed a failure in the coil's navigation, evidencing premature detachment.The entire access system with the coil was removed because fortunately most of it was still in the microcatheter.A new access was made and new coils were used without interference." incident report form submitted for this complaint indicates that no patient injury was sustained.Update 28jul2025- additional information received from the issuer:.Did the procedure involve tortuous anatomy? yes.Tortuous anatomy.Attached are images of the surgery.2.Will the microcatheter be available for return? no.The microcatheter was discarded along with the other materials.3.Where did the implant prematurely detach? (inside the an, inside the mc?, etc) the detachment occurred within the microcatheter, but part of the microcoil was already positioned in the aneurysm.The detachment occurred during coil positioning.4.Were any attempts made to detach the implant coil using the detachment controller? no.No attempt, because when the spring detached from the delivery wire it was no longer necessary to detach it.5.Can you confirm if the device was implanted? the device was not implanted.Using a microballoon, the coil and microcatheter were captured inside the long sheath, and the entire assembly was removed.Note: after this, a new access was created with the same access devices (including the same microcatheter), and other optima coils were used without complications.

• 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: 22906102
• Report Number: 3014162263-2025-00078
• Device Sequence Number: 8932152
• Product Code: HCG
• UDI-Device Identifier: 00818053026379
• UDI-Public: (01)00818053026379(11)221005(17)271005(10)F220900886
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/27/2025

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: OPTI0923CST10
• Device Lot Number: F220900886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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