MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0620CSFMX
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "patient information.Sex: unknown; disease name: 7 mm aneurysm in ic-pc; procedure: planned procedure; micro catheter: sl-10/stryker; assist stent: atlas/stryker, elvis/terumo; y connector: unknown; used coils: as per below.Description.For an aneurysm of approximately 7 mm, the physician placed a target xl 6-20 into the aneurysm as a framing coil, but it did not fit well, so two optimax 6-20s were placed, but both unraveled.When the physician used the first optimax 6-20 (lot# f231000599), the implant coil was placed in the aneurysm without realizing that the microcatheter had ruptured the bleb.Because the implant coil was displaced from the aneurysm, the young surgeon pulled on the coil, resulting in a slight unraveling of the implant coil.(it will be reported as (b)(4).) the second optimax 6-20 (lot# f231100245) was unraveled in the process of the physician repositioning the coil about 10 times.(it will be reported as (b)(4).) both the first and second optimax 6-20 could be detached.The procedure was completed in a position to suppress the unraveling parts of the two optimax 6-20's by arranging the stents (atlas 4.5x30, atlas 4x21, lvis 5.5x30, and lvis 4.5x28).The physician recognizes that the defect was not caused by the product, but by the procedure, but comments that the implant coils would not have been unraveled because it is a procedure that is performed all the time at target xl.This event took around 15 minutes.It is unknown whether the before use check was performed or not.The lot number of the used xcel was f231200248." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference: #(b)(4).An evaluation of the actual complaint sample could not be performed as device was unavailable to be 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 f231000599 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: 19549050
• Report Number: 3014162263-2024-00034
• Device Sequence Number: 11945560
• Product Code: HCG
• UDI-Device Identifier: 00818053025211
• UDI-Public: (01)00818053025211(11)231018(17)281018(10)F231000599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/17/2024

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: OPTI0620CSFMX
• Device Lot Number: F231000599
• 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: 05/20/2024
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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