MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0204HSS10
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 the complete coil system was included with the device return; we noted the returned coil system was not able to be introduce to the returned introducer sheath; we observed multiple minor and major kinks along the implant coil, however no visual signs of stretching were observed along the implant coil; 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 associated microcatheter was not returned with the coil system.Root cause of the reported issue cannot definitively be determined as no visual signs of stretching were observed along the implant coil or delivery pusher.Upon the return of the device, we observed multiple minor and major kinks along the implant coil.In addition, we observed multiple minor and major kinks along the hypotube.From our observations, it's possible the coil system was damaged from encountering friction, and became kinks following attempts to advance and retract the coil system.If the implant coil had become damaged within the microcatheter from encountering friction, this can make it difficult to advance the coil system within the microcatheter and lead to the implant coil becoming stretched upon retracting.Moreover, it is unknown if the microcatheter associated with the incident was damaged, which could have caused friction during advancement attempts and potentially lead to the reported issue.It is indicated in the lhr that the unit underwent 100% inspection which verifies that the implant was free of damage at the point of final inspection.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 f230900704 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: 19994920
• Report Number: 3014162263-2024-00057
• Device Sequence Number: 18233529
• Product Code: HCG
• UDI-Device Identifier: 00818053026683
• UDI-Public: (01)00818053026683(11)230922(17)280922(10)F230900704
• 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: OPTI0204HSS10
• Device Lot Number: F230900704
• 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: 09/22/2023
• 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