MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0254CSS10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference: #(b)(4).Investigation pending return of suspected device.25jun2025: additional information was received from the issuer regarding this incident.Therefore an updated reportability evaluation was documented which determined this incident should be upgraded to reportable based on the additional information received.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: "rt.Mca aneurysm coil embo./ associated products used : envoy 6fr, sl-10 c,s, prowler select plus j, enterprise2 stent synchro 14, coils.- pre-detach of coil in microcatheter during the procedure.- mca lesion, saccular type& wide neck, max size : 3.7mm, neck size : 2.7mm, ap 3.7*3.0, lat 3.6*3.2".Incident report form submitted for this complaint indicates that no patient injury was sustained.Update 25jun2025 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? synex confirmed 6/25) normal curvature.2.Will the microcatheter be available for return? synex confirmed 6/25) discarded after use (no issues occurred when using other coils).3.Where did the implant prematurely detach? (inside the an, inside the mc?, etc) synex confirmed 6/25) inside the microcatheter.4.Were any attempts made to detach the implant coil using the detachment controller? synex confirmed 6/25) not attempted.5.Can you confirm if the device was implanted? synex confirmed 6/25) removed from inside the microcatheter using syringe suction.".
Additional Manufacturer Narrative
Balt usa reference: #(b)(4).25jun2025: additional information was received from the issuer regarding this incident.Therefore an updated reportability evaluation was documented which determined this incident should be upgraded to reportable based on the additional information received.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 device return, we observed the delivery pusher was returned with minor kinks along the hypotube with the implant disconnected from the delivery pusher and not included in the return.During the device analysis, we conducted destructive analysis to reveal the profile of the sr thread which revealed the distal tip of the sr thread experienced a change in color and was opaque - indicating the thread endured an overload in tensile stress.Without the return of the implant coil its exact condition is unknown, however if it were to have become damaged, this can cause excessive friction within the microcatheter.Further attempts to retract the delivery pusher while the implant is damaged can ultimately lead to the observed mechanical detachment.Furthermore, it is unknown if the microcatheter associated with the incident was damaged, which could have contributed to the incident.However, 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 f250300484 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: "rt.Mca anuerysm coil embo./ associated products used : envoy 6fr, sl-10 c,s, prowler select plus j, enterprise2 stent synchro 14, coils.Pre-detach of coil in microcatheter during the procedure mca lesion, saccular type& wide neck, max size : 3.7mm, neck size : 2.7mm, ap 3.7*3.0, lat 3.6*3.2." incident report form submitted for this complaint indicates that no patient injury was sustained.Update 25jun2025 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? synex confirmed 6/25) normal curvature.2.Will the microcatheter be available for return? synex confirmed 6/25) discarded after use (no issues occurred when using other coils) 3.Where did the implant prematurely detach? (inside the an, inside the mc?, etc) synex confirmed 6/25) inside the microcatheter.4.Were any attempts made to detach the implant coil using the detachment controller? synex confirmed 6/25) not attempted.5.Can you confirm if the device was implanted? synex confirmed 6/25) removed from inside the microcatheter using syringe suction.".

• 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: 22618874
• Report Number: 3014162263-2025-00053
• Device Sequence Number: 8980287
• Product Code: HCG
• UDI-Device Identifier: 00818053025846
• UDI-Public: (01)00818053025846(11)250313(17)300313(10)F250300484
• 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): 08/29/2025

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: OPTI0254CSS10
• Device Lot Number: F250300484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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
• Patient Sex: Unknown