MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0320BLK
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference: # (b)(4).The returned device was inspected in our quality laboratory.During our analysis: we observed the coil system was not included with the device return.We observed only the introducer sheath was included with the device return.The inside diameter of the introducer sheath's distal tip measured to be within specification.The outside diameter of the introducer sheath's distal tip measured to be within specification.We noted that the in-house coil was able to advance through the returned introducer sheath with no issues.The introducer sheath was cut into 4 segments, the first cut being 5cm from its distal tip and the other segments being 5cm from the last cut.The introducer sheath's id was measured and found to be within specification.The introducer sheath's od was measured and found to be within specification.Root cause of the reported issue endured by the coil system cannot definitively be determined due to the incomplete device return.Upon return of the device, we observed the coil system was not included with the device return.Since the coil system was not returned, further introduction testing could not be conducted in order to attempt to replicate the reported failure.Based on the reported information, it is possible the implant coil had become separated from the delivery pusher following the incident.It is unknown if the implant was damaged during the use of the coil system.If the implant had become damaged during the use of the coil system, advancement of the damaged implant could have led to the reported introduction issues.It is indicated in the manufacturing records that the unit was free from visual damage at the point of the 100% final coil system 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 complaints against lot number f240801366 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.
Additional Manufacturer Narrative
Balt usa reference: # (b(4).Investigation pending return of suspected device.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: "after successful deployment of our first optiblock coil 5x40 in a fistula procedure we begin to load our 2nd coil 3x20 (f241100216) into the echelon catheter and we were met with resistance.The physician continued to push the coil as we're already in the body but it was clear the coil would not advance and had train recked in the mirco.We ended up having to remove the echelon and grab another.After successfully deploying 3 more coils with the new echelon micro catheter we tried to place another 3x20 (f240801366) coil.The physician was not happy with the placement and tried to reposition the coil 3 different times but it was clear the coil was too long.As we were trying to reshealth the coil the physician heard a pop and realized the coil had prematurely detached.We ended up having to snare the coil." incident report form submitted for this complaint indicates that no patient injury was sustained.
Event or Problem Description
It was reported that: "after successful deployment of our first optiblock coil 5x40 in a fistula procedure we begin to load our 2nd coil 3x20 (f241100216) into the echelon catheter and we were met with resistance.The physician continued to push the coil as we're already in the body but it was clear the coil would not advance and had train recked in the mirco.We ended up having to remove the echelon and grab another.After successfully deploying 3 more coils with the new echelon micro catheter we tried to place another 3x20 (f240801366) coil.The physician was not happy with the placement and tried to reposition the coil 3 different times but it was clear the coil was too long.As we were trying to reshealth the coil the physician heard a pop and realized the coil had prematurely detached.We ended up having to snare the coil.".Incident report form submitted for this complaint indicates that 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 ; 9497781443
• MDR Report Key: 22038479
• Report Number: 3014162263-2025-00025
• Device Sequence Number: 18219455
• Product Code: HCG
• UDI-Device Identifier: 00810068568950
• UDI-Public: (01)00810068568950(11)240829(17)290829(10)F240801366
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/03/2025

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: OPTI0320BLK
• Device Lot Number: F240801366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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