MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0310CSSMX
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2023
Type of Reportable Event	Malfunction
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 associated with the coil system was not returned; we observed the implant coil to be severely kinked throughout.We observed no visual damage to the detachment zone, with the lead wires and solder joints intact.We observed no visual indication of a detachment cycle being conducted.We observed the sr thread to be slightly opaque in color and broken at the proximal tip of the implant coil.We observed 2 minor kinks on the hypotube: 7cm proximal of the last warning strip and on the 2nd warning strip.Root cause of the premature detachment endured by the coil system can likely be attributed to an overload of tensile stress endured by the sr thread.Upon return of the device, the implant coil was observed to be severely kinked throughout.Device investigation showed no visual damage to the detachment zone, with the lead wires and solder joints intact.Further investigation revealed the sr thread to be found broken showing signs of tensile overload at the proximal tip of the implant coil.The thread showed no visual indication of a detachment cycle being attempted.It is unknown when and how the implant was damaged, but it is possible that the damaged implant caused friction along the microcatheter, possibly contributing to the reported issue.It is unknown if the microcatheter associated with the incident was damaged, possibly causing friction during the multiple manipulations to place the coil during the procedure 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 f220700599 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: "premature detachment.Physician "rode if out ~ 4.5 times w/ the microcatheter to work on placement.We retrieved if with a stentriever" "patient is unharmed".This occured during the embolization of an aneurysm.Sl-10 microcatheter.".

• 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: 16386162
• Report Number: 3014162263-2023-00002
• Device Sequence Number: 17427685
• Product Code: HCG
• UDI-Device Identifier: 00818053025051
• UDI-Public: 00818053025051
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPTI0310CSSMX
• Device Catalogue Number: N/A
• Device Lot Number: F220700599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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: Required Intervention
• Patient Sex: Unknown