MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0510CSFMX / OPTI0620CSFMX / OPTI1040CSFMX
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was discovered on july 8th, 2024, that product shipments had been made to japan using a wire component that was not approved for distribution within that region.
Additional Manufacturer Narrative
Balt usa reference:(b)(4).On 20jun2024 balt sent 12 units to japan distributor that had consumed raw material from an alternate supplier.Balt completed the material qualification of the raw material supplied by this alternate supplier,but has not received regulatory approval for this supplier change within the japan market and thus these units were not allowed to be shipped to this region.Release of tr22-093, rev.A indicates that the wire supplied by this alternate supplier is suitable for the production of the primary wind coil subassembly.Furthermore, a material assessment comparing the raw material between the primary supplier and this alternate supplier indicates that the materials from both suppliers are equivalent based on mechanical properties, material composition, critical dimensions and comparison of supplier manufacturing processes.Based on the results of tr22-093 and the approved material assessment, the units that were in question maintain equivalent residual risk to the patient with the commercial products since the material lot has been successfully qualified.The associated products were not distributed to the end user, and therefore have not been used.Further investigation, root cause, and corrective actions are to be performed under capa p-1067.

• 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: 19929439
• Report Number: 3014162263-2024-00055
• Device Sequence Number: 14134393
• Product Code: HCG
• UDI-Device Identifier: 00818053025167
• UDI-Public: (01)00818053025167(11)240410(17)290410(10)F240400445
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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
• Device Model Number: OPTI0510CSFMX / OPTI0620CSFMX / OPTI1040CSFMX
• Device Lot Number: REFER TO LISTED UDIS
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown