MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0308CSS10
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference #: (b)(4).Note: this complaint file is being reported late as part of a corrective action following an fda inspection.After a review of historical complaint files, it was determined that for this compaint the device failed to meet its performance specifications according to the initial claim submitted by the user.For these complaints, the potential harm did not lead to a serious injury or death, however the performance specification which was failed to be met for these complaints could have led to a serious injury or death based on the initial information that was reported to balt.The returned device was inspected in our quality laboratory.During our analysis: - we observed a red/brown substance found at the proximal tip of the introducer sheath; - we observed an additional darker substance found approximately 22cm from the proximal end of the introducer sheath, the coil system was retracted for further analysis; - we noted the brown substance found on the delivery pusher was able to be removed by lightly scraping the surface of the delivery pusher; - the introducer sheath was cut and found to have a similar red/black substance within the introducer sheath.The origin of the foreign matter that was found along the coil system cannot definitively be determined.Upon return of the coil system, the proximal end of the introducer sheath was found to have a red/brown substance, with additional darker substances found within the introducer sheath.After the coil system was retracted from the introducer sheath, the delivery pusher was found to have a light brown substance, which was able to be removed from the delivery pusher by lightly scraping the hypotube.Since the substance was able to be manually removed from the hypotube, it is unlikely that the substance is corrosion related.Based on previous product testing and previous composition testing performed by a third party laboratory, the ability to easily remove the foreign matter from the delivery pusher by scrapping the hypotube indicates that it is highly unlikely that the foreign matter is corrosion related.The submitted incident report form indicated that the incident occurred during use.It is unknown the origin of the foreign matter, but it is possible that the substance is human fluids (i.E.Blood).However the extent of the use of the coil system cannot be determined.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 f210100924 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.
Event or Problem Description
It was reported that: "there was foreign matter inside the coil sheath" incident report form received for this complaint indicated no patient injury was sustained.

• 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: 17572764
• Report Number: 3014162263-2023-00030
• Device Sequence Number: 12983302
• Product Code: HCG
• UDI-Device Identifier: 00818053025891
• UDI-Public: (01)00818053025891(11)210128(17)260128(10)F210100924
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2023

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: Health Professional
• Device Expiration Date: 01/28/2026
• Device Model Number: OPTI0308CSS10
• Device Lot Number: F210100924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2021
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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
• Patient Sex: Unknown