MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0204CSS10
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the user will like to know if the root cause of the coil implant not being present is a manufacturing issue.After opening the coil box and advancing in the coil sheath, the user detected an abnormality, and while deploying in vitro it was found that there was no implant." incident report form received for this complaint indicated no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference #(b)(4).Note: this complaint file is being reported late as part of a corrective action following an fda inspection.After a review of historical complaint files, it was determined that for this compaint the device failed to meet its performance specifications according to the initial claim submitted by the user.For these complaints, the potential harm did not lead to a serious injury or death, however the performance specification which was failed to be met for these complaints could have led to a serious injury or death based on the initial information that was reported to balt.The returned device was inspected in our quality laboratory.During our analysis: we observed the coil system to be returned with no implant; we observed the sr thread to be found opaque in color and fractured approximately 4mm distal of the detachment zone; we observed the sr thread to have a large diameter at the point of fracture; we observed the detachment zone to be found with no visual damage and no indications of a detachment cycle being ran; we observed the delivery pusher to be found with a minor kink approximately 39cm proximal of the hypotube's distal tip.Root cause of the implant issue cannot be definitively determined.Upon device return, the coil system was found with no implant connected to the delivery pusher with the sr thread opaque in color and fractured.At the point of fracture, the diameter of the sr thread was larger than the rest of the thread, indicating that the thread was stretched rapidly.It is unknown when or how the implant became disconnected from the delivery pusher, but it is possible that the coil system became damaged while removing the coil system from the dispenser hoop.It is unknown when or how the delivery pusher became kinked, but it is possible this occurred when removing the delivery pusher from the dispenser hoop or when attempting to introduce the coil system into the microcatheter hub.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 f210200041 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.

• 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: 17572740
• Report Number: 3014162263-2023-00029
• Device Sequence Number: 8877052
• Product Code: HCG
• UDI-Device Identifier: 00818053025792
• UDI-Public: (01)00818053025792(11)210208(17)260208(10)F210200041
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K172390
• 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): 08/01/2023

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 Expiration Date: 02/08/2026
• Device Model Number: OPTI0204CSS10
• Device Lot Number: F210200041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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
• Patient Sex: Unknown