MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0513CSS10
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during the procedure, the third coil could not be advanced into the aneurysm.Pushing the coil back and forth, pre-detach occurred.The unraveled coil was held in place against the vessel wall with a stent.The pre-detach caused a major complaint." update 16dec2024 - additional information received from the issuer: 9.How would the tortuosity be described in this procedure? taewoong's answer: there were no abnormalities.10.Can you confirm if the supplemental accessories will be returned? (microcatheter, etc) if so, it would be appreciated.Taewoong's answer: they will not be returned.11.Was the usage of the stent a result of this incident? taewoong's answer: the stent was used to fix the stretched implant coil to the vessel wall after pre-detach occurred." update 30dec2024 - additional information received from the issuer: "1.Can you confirm if the implant coil was able to advance out of the introducer sheath? taewoong's answer: it was able to advance out of the introducer sheath well.2.Did the procedure involve tortuous anatomy? taewoong's answer: yes, the anatomy was very tortuous.3.Will the microcatheter be available for return? taewoong's answer: the microcatheter used is not available for return.4.Where did the implant prematurely detach? (inside the an, inside the mc?, etc) taewoong's answer: it was detached inside the microcatheter.5.Were any attempts made to detach the implant coil using the detachment controller? taewoong's answer: it was impossible to implant the coil, so it was fixed in place at the vessel wall using a stent.For details, please refer to the photos and videos sent from before.6.Can you confirm if the device was implanted? taewoong's answer: please see the answer for 5." incident report form submitted for this complaint indicates that no patient injury was sustained.
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 f230401018 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.

• 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: 21150103
• Report Number: 3014162263-2024-00109
• Device Sequence Number: 9330508
• Product Code: HCG
• UDI-Device Identifier: 00818053025990
• UDI-Public: (01)00818053025990(11)230429(17)280429(10)F230401018
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/14/2025

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: OPTI0513CSS10
• Device Lot Number: F230401018
• 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: 12/15/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2023
• 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