MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0154HSS10
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference # (b)(4) investigation pending return of suspected device.The initial notification of this event was received on 11/19/2024, for which the event details were assessed and determined the event did not meet any regulatory reporting requirements.Additional information received from the issuer regarding the case on 12/02/2024, for which the complaint file was re-assessed for reportability and concluded that based on the additional information received, this complaint file will be updated to a reportable event.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 inserting the coil in the aneurysm, the pusher was slightly pulled back due to microcatheter kick back.There was a detaching sound, and the coil was pre-detached and stretched." update 02dec2024 - additional information received from the issuer: "· where did the implant coil prematurely detach (within the microcatheter, partially outside of the microcatheter, within the aneurysm, etc.)? taewoong's answer: inside the aneurysm.After the implant coil prematurely detached, how did the case conclude? taewoong's answer: after removing the coil with a snare, a stent was deployed." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference (b)(4).The returned device was inspected in our quality laboratory.During our analysis: - we observed the implant coil and introducer sheath was not included with the device return; - we observed no sign of detachment cycle being ran; - we observed no visual damage to the detachment zone with the pet jacket, lead wires and solder joints intact; - we observed multiple minor kinks along the hypotube; - we observed the microcatheter was not return; - we conducted destructive testing of the delivery pusher to reveal the detachment profile of the sr thread; - we observed the distal tip of the sr thread is opaque in color - indicating the thread endured an overload in tensile stress.Root cause of the reported issue can likely be attributed to an overload of tensile stress exerted on the implant coil.Upon return of the device, we observed no sign of detachment cycle being ran.In addition, we observed the profile of the distal end of the sr thread to indicate that the thread endured an overload in tensile stress.Without the return of the implant coil its exact condition is unknown, however it is possible that the implant coil had become damaged during attempts to advance the coil system into the treatment location, then resulting attempts to retract the delivery pusher ultimately led to the premature detachment.Furthermore, it is unknown if the microcatheter associated with the incident was damaged, which could have caused friction during advancement attempts and potentially lead to the reported premature separation.This could not be further investigated without the return of the associated microcatheter.It is indicated in the lhr that the unit underwent 100% inspection which verifies that the implant was free of damage at the point of 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 complaint against lot number f230605235 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 initial notification of this event was received on 11/19/2024, for which the event details were assessed and determined the event did not meet any regulatory reporting requirements.Additional information received from the issuer regarding the case on 12/02/2024, for which the complaint file was re-assessed for reportability and concluded that based on the additional information received, this complaint file will be updated to a reportable event.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 inserting the coil in the aneurysm, the pusher was slightly pulled back due to microcatheter kick back.There was a detaching sound, and the coil was pre-detached and stretched." update 02dec2024 - additional information received from the issuer: "· where did the implant coil prematurely detach (within the microcatheter, partially outside of the microcatheter, within the aneurysm, etc.)? taewoong's answer: inside the aneurysm.· after the implant coil prematurely detached, how did the case conclude? taewoong's answer: after removing the coil with a snare, a stent was deployed." 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: 21027276
• Report Number: 3014162263-2024-00103
• Device Sequence Number: 12839761
• Product Code: HCG
• UDI-Device Identifier: 00818053026645
• UDI-Public: (01)00818053026645(11)230621(17)280621(10)F230605235
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 01/27/2025

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: OPTI0154HSS10
• Device Lot Number: F230605235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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