MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0203CSS10
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during the procedure the coil was stretched and was taken out of the body with solitaire stent.Total of 3 optima coil stretch defects occurred in the procedure, so 1 coil and 2 delivery system will be returned.2 of the coils were lost during the retrieval with the solitaire stent.It was difficult to visually distinguish the returned coil implant from the 3 stretch failure, so the label will be attached." update 18jul2024: additional information received from the issuer: "when exactly did the stretching occur for each of the three coils? when positioning the coil by inserting and removing.Was the stent device used only to retract one coil? or was a stent device used for each of the three stretched coils? one stent was used to remove 3 coils.Did the patient sustain any injury? no when it is mentioned that "2 of the coils were lost during the retrieval with the solitaire stent", what was the outcome of this process? what happened to these two coils? it was discarded with the solitaire stent." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference #: (b)(4).The returned device was inspected in our quality laboratory.During our analysis: we observed the implant coil was not included with the device return.We observed no visual damage to the detachment zone with the pet jacket, lead wire, solder joints and sr thread intact.We observed multiple minor and major kinks along the hypotube.We noted the detachment zone did not show visual signs of a detachment cycle being ran.Root cause of the reported issue endured by the coil system cannot definitively be determined due to the incomplete device returned.Upon return of the device, we observed multiple minor and major kinks along the hypotube.The exact damage sustained by the implant coil cannot be confirmed as it was not included with the returned delivery pusher for analysis.If the implant coil were to have become damaged, this can lead to the user encountering friction and subsequently causing the implant coil to stretch when retracting the coil system.It is indicated in the manufacturing records that the unit was free from visual damage at the point of the final coil system inspection.Further device analysis could not be performed as the associated implant coil was not returned.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaint against lot number f230300605 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 92618
• MDR Report Key: 19994452
• Report Number: 3014162263-2024-00056
• Device Sequence Number: 7087513
• Product Code: HCG
• UDI-Device Identifier: 00818053025785
• UDI-Public: (01)00818053025785(11)230321(17)280321(10)F230300605
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/15/2024

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: OPTI0203CSS10
• Device Lot Number: F230300605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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