MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0611CSFMX
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician was treating an 8mm pcomm ruptured aneurysm with mutiple lobes.We started out by using a 7 x 15mm optimax through an sl-10.Upon not being able to get the coil to sit properly, the physician introduced an echelon 10 micro and the 6mm x 11cm optimax to try and get the coils to play off one another.With both catheters and coils in the aneurysm, we were able to get the 7 x 15mm optimax to sit and detatched the coil.Following detatchment, we manipulated the 6mm x 11cm coil a bit and it prematurely detatched, half the coil was in the aneurysm and the other half was in the parent vessel.There was too much coil hanging into the parent vessel to try and lay a stent.We ended up having to snare the coil out of the body.We did so successfully.While snaring out the 6mm coil, it ended up pulling the 7mm detatched coil into the top part of the aneurysm and into the parent vessel.We then had to use a stentriever to pull out of the 7mm coil as well.Following all those events, we ended up laying an atlas stent and proceeded to coil the aneurysm successfully." update 15may2025 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? 2.Will the microcatheter be available for return? 3.Where did the implant prematurely detach? (inside the an, inside the mc?, etc) 4.Were any attempts made to detach the implant coil using the detachment controller? 5.Can you confirm if the device was implanted? 1.No 2.No but the pusher and premature detached coil are available for return 3.Inside the aneurysm 4.No 5.The device was not implanted; we had to remove it with a snare." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference: # (b)(4).Investigation pending return of suspected device.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.
Additional Manufacturer Narrative
Balt usa reference: #(b)(4) an evaluation of the actual complaint sample could not be performed as the 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 f250200170 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 an 8mm pcomm ruptured aneurysm with mutiple lobes.We started out by using a 7 x 15mm optimax through an sl-10.Upon not being able to get the coil to sit properly, the physician introduced an echelon 10 micro and the 6mm x 11cm optimax to try and get the coils to play off one another.With both catheters and coils in the aneurysm, we were able to get the 7 x 15mm optimax to sit and detatched the coil.Following detatchment, we manipulated the 6mm x 11cm coil a bit and it prematurely detatched, half the coil was in the aneurysm and the other half was in the parent vessel.There was too much coil hanging into the parent vessel to try and lay a stent.We ended up having to snare the coil out of the body.We did so successfully.While snaring out the 6mm coil, it ended up pulling the 7mm detatched coil into the top part of the aneurysm and into the parent vessel.We then had to use a stentriever to pull out of the 7mm coil as well.Following all those events, we ended up laying an atlas stent and proceeded to coil the aneurysm successfully." update 15may2025 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? 2.Will the microcatheter be available for return? 3.Where did the implant prematurely detach? (inside the an, inside the mc?, etc) 4.Were any attempts made to detach the implant coil using the detachment controller? 5.Can you confirm if the device was implanted? 1.No 2.No but the pusher and premature detached coil are available for return 3.Inside the aneurysm 4.No 5.The device was not implanted; we had to remove it with a snare." 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 the 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 f250200170 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 an 8mm pcomm ruptured aneurysm with multiple lobes.We started out by using a 7 x 15mm optimax through an sl-10.Upon not being able to get the coil to sit properly, the physician introduced an echelon 10 micro and the 6mm x 11cm optimax to try and get the coils to play off one another.With both catheters and coils in the aneurysm, we were able to get the 7 x 15mm optimax to sit and detached the coil.Following detachment, we manipulated the 6mm x 11cm coil a bit and it prematurely detatched, half the coil was in the aneurysm and the other half was in the parent vessel.There was too much coil hanging into the parent vessel to try and lay a stent.We ended up having to snare the coil out of the body.We did so successfully.While snaring out the 6mm coil, it ended up pulling the 7mm detatched coil into the top part of the aneurysm and into the parent vessel.We then had to use a stentriever to pull out of the 7mm coil as well.Following all those events, we ended up laying an atlas stent and proceeded to coil the aneurysm successfully." update 15may2025 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? 2.Will the microcatheter be available for return? 3.Where did the implant prematurely detach? (inside the an, inside the mc?, etc) 4.Were any attempts made to detach the implant coil using the detachment controller? 5.Can you confirm if the device was implanted? 1.No 2.No but the pusher and premature detached coil are available for return 3.Inside the aneurysm 4.No 5.The device was not implanted, we had to remove it with a snare".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: 22196507
• Report Number: 3014162263-2025-00037
• Device Sequence Number: 12971065
• Product Code: HCG
• UDI-Device Identifier: 00818053025198
• UDI-Public: (01)00818053025198(11)250206(17)300206(10)F250200170
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup,Followup
• Report Date (Section B): 10/14/2025

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: OPTI0611CSFMX
• Device Lot Number: F250200170
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 05/13/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 09/30/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown