MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0208CSS10
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference #(b)(4).The returned device was inspected in our quality laboratory.During our analysis: the single unit returned from the distributor was evaluated for the accuracy of the pouch and shelf carton label.During the evaluation of this complaint, the pouch of the unit was opened and the coil was measured to be a 2mm x 8cm complex super soft coil (measured according to inspection note for top level assembly), when the product pouch indicated a 3mm x 8mm complex super soft coil and the shelf carton label indicating a 2mm x 8cm complex super soft coil.Therefore the size of the implant coil was correctly indicated on the shelf carton label, however the implant size indicated on the product pouch was larger than the actual size of the implant coil.This malfunction is being reported following an observation made during fda inspection.To date, all affected products have since been recalled, accounted for entirely, and subsequently scrapped.Corrective action has since been implemented and verified to be effective as documented under the associated capa file.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.
Event or Problem Description
It was reported that: "this is to inform you that we found a product whose information on the pouch label differs from the label on the box during incoming inspection.As of now the amount of product with discrepancy is 1.Box: opti0208css10 f220601068 pouch: opti0308css10 f220601089".

• 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: 17313322
• Report Number: 3014162263-2023-00022
• Device Sequence Number: 6116007
• Product Code: HCG
• UDI-Device Identifier: 00818053025815
• UDI-Public: (01)00818053025815(11)210922(17)260922(10)F220601068
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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: Other
• Device Expiration Date: 09/22/2026
• Device Model Number: OPTI0208CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F220601068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2021
• 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: Other
• Patient Sex: Unknown