MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0408CSS10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "indeed, there was an uncontrolled detachment (the equipment was released without the planned detachment system: by the electric detacher).The material was therefore found intracranial in the cerebral arterial flow." 13dec2022, additional information provided by issuer: translation french to english: "could you tell us if this incident was notified to the ansm? : yes.Could you tell us how the doctor completed the procedure? (use of a new coil): the doctor resorted to emergency aspiration through a thrombectomy catheter (sofia 6f) to retrieve the coil.Could you tell us if the doctor carried out an additional intervention? : the doctor has stopped the intervention." issuer confirmed no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference (b)(4).Completion of 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).The returned device was inspected in our quality laboratory.During our analysis: - we noted that the introducer sheath and delivery pusher associated with the coil system were not returned, only the implant coil was returned; - we observed minor kinks along the distal end of the returned implant coil; - we observed dry blood on the distal end of the implant coil; - we noted that further detachment or introduction testing could not be conducted due to the unreturned delivery pusher and introducer sheath.Root cause of the premature detachment endured by the coil system cannot be definitively determined due to the incomplete device return.Device investigation showed only minor visual damage to the implant coil returned.Since the delivery pusher was not returned, it is unknown whether the delivery pusher sustained kinks or if the detachment zone was damaged, which could have contributed to the reported issue.If the detachment zone was damaged prior to introduction, this could have caused friction through the microcatheter, leading to the premature detachment.It is unknown if the microcatheter associated with the incident was damaged, possibly causing friction during advancement attempts and contributing to the reported premature separation.Further investigation of the reported issue could not be conducted due to the unreturned delivery pusher and introducer sheath.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 f220600147 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: "indeed, there was an uncontrolled detachment (the equipment was released without the planned detachment system: by the electric detacher).The material was therefore found intracranial in the cerebral arterial flow." 13dec2022, additional information provided by issuer - translation french to english: "- could you tell us if this incident was notified to the ansm? : yes.- could you tell us how the doctor completed the procedure? (use of a new coil): the doctor resorted to emergency aspiration through a thrombectomy catheter (sofia 6f) to retrieve the coil.- could you tell us if the doctor carried out an additional intervention? : the doctor has stopped the intervention.Issuer confirmed 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: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 16103368
• Report Number: 3014162263-2022-00042
• Device Sequence Number: 11563172
• Product Code: HCG
• UDI-Device Identifier: 00818053025945
• UDI-Public: 00818053025945
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPTI0408CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F220600147
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown