MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0256CSS10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference (b)(4).Note: this complaint file is being reported late as part of a corrective action following an fda inspection.After a review of historical complaint files, it was determined that for this compaint the device failed to meet its performance specifications according to the initial claim submitted by the user.For these complaints, the potential harm did not lead to a serious injury or death, however the performance specification which was failed to be met for these complaints could have led to a serious injury or death based on the initial information that was reported to balt.The returned device was inspected in our quality laboratory.During our analysis: we noted that the implant was not returned; we noted that the introducer sheath associated with the coil system was not returned; we observed no visual damage to the detachment zone, with the lead wires and solder joints intact; we noted that a detachment cycle was not attempted; the body coil was pulled back and the sr thread was not visible; the sr thread was not visible at the body coil gap; we observed no other visual damage along the delivery pusher.Root cause of the premature detachment endured by the coil system cannot be definitively determined due to the incomplete device return.Upon return of the device, the coil was observed to be detached from its delivery pusher and not returned; the introducer sheath was also not returned.Device investigation showed no visual damage to the detachment zone, with the lead wires and solder joints intact.Further investigation showed that the sr thread was not present at the body coil and could have been removed with the implant at the premature detachment point.It is unknown if the implant was damaged, possibly causing friction along the microcatheter and contributing to the reported premature separation.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 f211100387 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 the 0256css coil was inserted into the aneurysm, it suddenly detached and around half was floating and blocking the blood vessel.The physician pushed in a 0154css and took emergency measures, but the blood vessel from the outside of the aneurysm to the pcom was blocked.Therefore, after removing the 0154css, it was re-adjusted.Fortunately, it was judged that there was no significant harm to the patient and the procedure was closed." 09nov2022, additional information provided by issuer - "·regarding the unit under reference ((b)(6)): was the 0154css coil a part of the initial planned procedure or was this a physician intervention? (b)(6)'s answer: both are correct.The doctor planned on using it after 0256css, but since the 0256css was pre-detached 0154css was used.Was a detachment cycle attempted for the 0256css coil? taewoong's answer: the problem occurred because it was detached without detachment attempt.Can you confirm that the 0154css coil was not detached in the aneurysm? taewoong's answer: there were no problems with 0154css coil.0256css was not detached, and could not be completely pushed with 0154css, so it was slightly protruded into the blood vessel." incident report form received for this complaint indicates 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: 17573384
• Report Number: 3014162263-2023-00046
• Device Sequence Number: 15520791
• Product Code: HCG
• UDI-Device Identifier: 00818053025853
• UDI-Public: (01)00818053025853(11)211109(17)261109(10)F211100387
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K172390
• 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): 08/08/2023

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: OPTI0256CSS10
• Device Lot Number: F211100387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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
• Patient Sex: Unknown