MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0220BLK
Medical Device Problem Codes	Stretched (1601); Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
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 f250300724 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: "when resheathing the 2x20 coil in the headway duo 156cm microcatheter in the mma, the coil stretched and then broke off the delivery wire.The coil was not able to be recaptured and was left in the eca where it broke off.Fortunately, no patient harm.The same microcatheter was used to deliver coils for the remainder of the case." update 23jun2025 - additional information received from the issuer: " is it known approximately where the actual "break" along the coil took place (did it occur at the detachment zone, did the implant coil wind break, etc.)? the actual coil implant stretched midway through and then broke at the detachment zone.Where it is mentioned "when resheathing the 2x20 coil in the headway duo 156cm microcatheter in the mma", does this mean the implant was deployed from the mc and the physician was attempting to retract back into the microcatheter? the microcatheter was kicking back as he was trying to deploy the coil, so there was some resheathing of the coil inside the microcatheter to reposition.Based on the anatomical location of the procedure, what level of vessel tortuosity would you consider was encountered by the coil system? there was an average level of tortuosity.Since the implant coil was unable to be recaptured, did the physician need to perform any additional intervention to correct this incident? no fortunately the coil landed in a place that was safe to leave in the patient.No patient harm caused by the coil being left where it broke off." 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: 22546351
• Report Number: 3014162263-2025-00051
• Device Sequence Number: 15203879
• Product Code: HCG
• UDI-Device Identifier: 00840303711858
• UDI-Public: (01)00840303711858(11)250321(17)300321(10)F250300724
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/18/2025

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: OPTI0220BLK
• Device Lot Number: F250300724
• 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: 06/20/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• 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: Other
• Patient Sex: Unknown