MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0304CSS10
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: " 1.When exactly did the stretching occur for each of the three coils? - when positioning the coil by inserting and removing.2.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.3.Did the patient sustain any injury? - no 4.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 only the implant coil were included with the device returned; we observed the delivery pusher and introducer sheath were not included with the device returned we observed the implant coil to be severely stretched.We observed the sr thread within the implant coil to be opaque.Root cause of the reported issue can likely be attributed to excessive tensile stress endured by the implant coil leading to the implant to become stretched.During our evaluation, we observed the implant coil to be severely stretched and we observed the sr thread within the implant coil to be opaque.The returned implant coil was evaluated, and found to have severe damage throughout the implant coil including stretching.Based on the reported information, the implant coil became stretched as the user was manipulating the coil system at the treatment location.The exact cause of the stretched implant is unknown, however if the implant coil were to have become partially damaged, this could have led to excessive friction being forced on the implant coil and lead to the coils become stretched.As the implant coil was retrieved by the user, it is likely that additional stretching took place at that time, however the extent to which is unknown.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 introducer sheath and delivery pusher were 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 complaints against lot number f230500393 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; irvince CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618
• MDR Report Key: 19994840
• Report Number: 3014162263-2024-00058
• Device Sequence Number: 20940588
• 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: OPTI0304CSS10
• Device Lot Number: F230500393
• 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