MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0310CSS10
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "patient information: sex: unknown.Disease name: davf.Procedure: planned procedure for davf.Micro catheter: unknown.Guide wire: unknown.Used coils:10 the other coils including competitive product.Description: after detachment of the optima, the physician retrieved delivery pusher and found that the fluoroscopy suggested the possibility of unraveling the implant coil in target lesion.The physician managed to retrieve unraveled coil with snare.The proximal end of retrieved coil was certainly unraveled.Although 10 other coils including competitive device had been placed the target lesion at that point (the complaint optima was 11th coil in the procedure), the physician determined that the retrieved coil looks optima.The procedure was finished without any further treatment.The physician also commented that it might be caused by too early withdrawal of delivery pusher which might have hooked and dragged implant coil.Thus, the physician does not assume it product defect and the facility discarded coil system." incident report form submitted for this event indicated no patient injury was sustained as a result of this incident.
Additional Manufacturer Narrative
Balt usa reference #(b)(4).An evaluation of the actual complaint sample could not be performed as the device was unavailable for 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 f201100278 have 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: 17515365
• Report Number: 3014162263-2023-00024
• Device Sequence Number: 5536742
• Product Code: HCG
• UDI-Device Identifier: 00818053025907
• UDI-Public: (01)00818053025907(11)201118(17)251118(10)F201100278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/21/2023

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: 11/18/2025
• Device Model Number: OPTI0310CSS10
• Device Lot Number: F201100278
• 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: 07/14/2023
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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