MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0152CSSMX
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
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 returned; we observed multiple major kinks and minor stretching along the implant coil; we observed the sr thread of the body coil is opaque and connected to the implant coil and measured to be 5cm from the proximal tip of the implant coil; we noted the associated microcatheter was not included in the device return.Based on the available information and the investigation results the complaint can be confirmed.Root cause of the reported issue endured by the coil system can likely be attributed to excessive tensile stress exerted on the implant coil, leading to the premature detachment.Upon return of the device, we observed only the implant coil was returned for analysis without the associated delivery pusher and introducer sheath.We observed multiple minor kinks along the implant coil in addition to stretching, however the exact timing of when this damaged occurred is unknown.The sr thread connected to the implant coil was found to be opaque in color, indicating the thread had likely failed due to an overload of tensile stress.Underwent excessive tensile stress.Without the return of the delivery pusher used during the event, further evaluation of the internal sr thread could not be performed to confirm the characteristics of the thread within the delivery pusher.A review of the lhr indicated that the unit was free from visual damage, including the implant coil at the point of the 100% 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 complaints against lot number: f210700389 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: "during embolization of an acom aneurysm, the physician positioned an sl-10 microcatheter within the aneurysm and requested an optimax ss 1.5 x 2 coil.As the coil was advanced through the microcatheter, it was visualized under fluoroscopy within the catheter.However, upon advancing the final quarter of the coil into the aneurysm, loss of one-to-one response occurred, and the coil could neither be advanced nor retracted.Using the delivery wire, the physician was able to advance the remaining portion of the coil into the aneurysm.Follow-up imaging demonstrated the 1.5 x 2 optimax coil positioned at the aneurysm neck and within the acom.On subsequent imaging, the coil had migrated into the a2 segment.The delivery wire was removed, and the sl-10 microcatheter was withdrawn.The physician urgently requested a trevo retrieval system, including a trak 21 microcatheter and trevo stent retriever.Multiple attempts were made to retrieve the migrated coil, during which the coil continued to move distally.After three passes, successful retrieval was achieved using a larger trevo stent retriever.The coil was prepared according to the dfu.The delivery wire and coil are available for return." 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: 25332925
• Report Number: 3014162263-2026-00060
• Device Sequence Number: 9954248
• Product Code: HCG
• UDI-Device Identifier: 00818053024955
• UDI-Public: (01)00818053024955(11)210722(17)260722(10)F210700389
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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 Expiration Date: 07/22/2026
• Device Model Number: OPTI0152CSSMX
• Device Lot Number: F210700389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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