MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0427BLK
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
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 f250300250 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 was treating a vogn on a 3 day old patient.He got common femoral artery access and used standard techniques to reach the vogn junction.Using a headway duo, the physician attempted to deploy an optiblock 4x27 which would not sit at the junction.Due to the high flow, the coil was going into the malformation.The physician felt the 4x27 coil was too small and chose to remove the coil and input a 5x40 optiblock.The 5x40 was not sitting at the junction either and appeared to be too small which was causing it to go into the malformation.The 5x40 coiled inside the catheter and stretched so they decided to use it for research to obtain cells from the malformation.Upon completion of collecting cells, the physician grabbed the 4x27 optiblock from the back table and tried to re-deploy it in the same location.Flow was extremely high and the coil kept prolapsing into the main malformation so he pulled back slightly and the coil went into a feeder.Three loops formed in the feeder and the physician called out that the coil was "stuck." upon trying to remove the coil from the segment it was stuck in, the coil detached and the "tail" of the coil extended all the way to the access site - femoral artery.The physician quickly deployed a 4x20 block to anchor the deployed distal coil and then followed up with a 3x10 block to secure it.After hours of trying to get the tail of the coil to form in the coil pack, dr.Determined he'd be unable and would finish case.The tail of the coil is currently extending down into femoral artery." incident report form submitted for this complaint indicates that no patient injury was sustained.Update 21may2025 - additional information received from the issuer: "patient is stable.The ultrasound showed no visible thrombus." update 04jun2025 - additional information received from the issuer: "1.For the 5 x 40 coil, it is mentioned that "the 5x40 coiled inside the catheter and stretched." can you confirm the location within the catheter that this took place? the coil stretched when he pushed the coil out and it didn't form and then pulled it back into the tip of the microcatheter.The flow was extremely high and coil wasn't sitting correctly so he tried to pull back into micro and that's when it stretched.He then just used it to test the cells for research.".

• 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: 22286693
• Report Number: 3014162263-2025-00039
• Device Sequence Number: 8551352
• Product Code: HCG
• UDI-Device Identifier: 00840303711902
• UDI-Public: (01)00840303711902(11)250306(17)300306(10)F250300250
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: OPTI0427BLK
• Device Lot Number: F250300250
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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; Required Intervention
• Patient Sex: Unknown