MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0103CSS10
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "patient information: sex: unknown, disease name: 4 mm aneurysm with bleb in a-com, procedure: emergency procedure, micro catheter: sl-10/stryker, phenom 17/medtronic, assist stent: unknown, y connector: unknown, used coils: as per below.Description: the physician attempted to framing the bleb using a target tetra (stryker) as the first coil.The target tetra coil was damaged in the process of repositioning and pulling back into the sl-10 microcatheter.Therefore, the entire microcatheter, including the coil, was retrieved with a snare and replaced with a new microcatheter, phenom17.After that, the optima 3x4 was placed as a framing coil, and the target nano (stryker) was placed.Then, the physician used the reported optima1x3 (lot# 211000213) and once in the process of pulling it back into the microcatheter for repositioning, and the physician felt the coil shredded and found the coil detached early inside the microcatheter.During use, the tip of the microcatheter was near the central area of the aneurysm, and there was no appearance of a loading force on the tip of the microcatheter.The coil was retrieved by pulling it into the microcatheter with the esperance¿ dac catheter.(it will be reported as ya2024-0228.) after continued use of the phenom17 and placing 5 optima implant coils, the physician used the optima1x2 (lot# 221000323) as the last coil.When the physician tried to insert the coil into the microcatheter, it would not come out form tip of introducer sheath.Then the physician stopped usage of the coil and completed the procedure.(it will be reported as ya2024-0231.) note; the procedure did not involve tortuous anatomy.It is unknown whether the before use check was performed or not." 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 f211000213 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 92818 ; 9498771443
• MDR Report Key: 19615571
• Report Number: 3014162263-2024-00037
• Device Sequence Number: 20569952
• Product Code: HCG
• UDI-Device Identifier: 00818053025723
• UDI-Public: (01)00818053025723(11)211009(17)261009(10)F211000213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/26/2024

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: OPTI0103CSS10
• Device Lot Number: F211000213
• 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: 05/27/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown