MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0407CSF10
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "they say inside de external the reference was different than the one on the external box outside card box label opti0407csf10 f210500135, inside contain opti0204csf10 du lot f210500134.Product was not use and pouch remain un opened (closed) we can bring back all before use.".
Additional Manufacturer Narrative
Balt usa reference complaint #(b)(4).The unit with the label discrepancy has been returned to balt usa under rga (b)(4).This complaint has triggered the opening of hhe-(b)(4) (balt usa co#(b)(4)) and ncmr (b)(4) to drive completion of the hhe.Any further corrective action and investigation will be documented under the hhe and ncmr.(b)(6) 2021: while preparing hhe-(b)(4), the initial assessment of this complaint file was re-evaluated due to feedback received from the regulatory department regarding the hhe.Upon initial assessment, the assumption of the label discrepancy was made that the shelf carton label was incorrect, and the pouch label was correct according to the lhr.As recorded in balt usa ncmr (b)(4), one additional unit was returned from balt extrusion under rga (b)(4) ((b)(6) 2021) after this complaint had already been closed.At the time of the initial assessment, the device pouch was not opened knowing that the unit had potential to be reworked.During the re-evaluation of this complaint, the pouch of both units were opened and the length of the implant was found to be 7cm, therefore the shelf carton label is correct and the pouch label is incorrect.This additional evaluation has been documented in balt usa ncmr (b)(4) and hhe-(b)(4).(b)(6) 2022: initial reportability decision tree deemed this event as not reportable.Reportability decision tree was not updated after the additional information was received regarding this incident.Reportability decision tree has been updated and has been deemed reportable.Notification of urgent field safety notice (fsn) / product recall was issued 04jan2022 with the reference "fsn #: 3014162263-01/04/22-001-r" for inside the united states.Additional reference "(b)(4)_optima labeling mix-up" used for outside the united states.Fda acknowledgement letter reference res# (b)(4).

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 13389359
• Report Number: 3014162263-2022-00005
• Device Sequence Number: 13881973
• Product Code: HCG
• UDI-Device Identifier: 00818053026096
• UDI-Public: 00818053026096
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/28/2022

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: 05/15/2026
• Device Model Number: OPTI0407CSF10
• Device Catalogue Number: N/A
• Device Lot Number: F210500135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2021
• 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