MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0208HSS10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
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 implant coil and introducer sheath were not returned with the delivery pusher; we observed signs of a detachment cycle attempted at the detachment zone, with the pet jacket showing signs of a thermal detachment; we observed a bend on the hypotube 12cm proximal from the last warning stripe; we observed the sr thread within the delivery pusher to show detachment characteristics indicating that a thermal detachment occurred.Root cause of the reported premature detachment endured by the coil system cannot definitively be determined as the analysis of the returned delivery pusher does not reveal supporting evidence that a premature detachment occurred.During the device analysis, the pet jacket around the detachment zone showed signs that a thermal detachment cycle was ran through the returned delivery pusher.Further evidence indicating that a premature detachment did not take place was supported by the detachment characteristics of the sr thread within the delivery pusher.The thread was located just proximal of the detachment zone with the distal tip of the thread indicating that a thermal detachment was performed.The description provided states the implant coil prematurely detached within the microcatheter during the procedure, however device analysis indicates a detachment cycle was successfully performed on the returned delivery pusher.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 f230400361 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: "it was a case of acom aneurysm measuring 5.7mm*5mm with neck of 2 mm the physican planned to do simple coiling.The support system was vista brite 90cm and fargomax, the vasco10d was placed inside the aneurysm with support of hybrid1214d.The vasco10d was connected with a flush line.The coil was prepared as per ifu and then aligned to the hub of the micro catheter, the first coil size of 5mm*13mm optima complex10 was taken on introduzing, the coil went smoothly through the sleeve into the hub of vasco10 and detached later took 4mm*13mm optima complex10 and detached next physician took 2mm*8mm optima helical supersoft the coil went smoothly through the sleeve into the hub.Physician was pushing the coil into aneurysm but the coil was not moving later physician was reterving coil but no movement was happening.Coil had pre detached but the coil was removed with the help of catchmaxi40 coil been taken out and physician decided to leave and case was completed without issue." incident report form submitted for this event indicated no patient injury was sustained as a result of this incident.

• 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 92618 ; 9497881443
• MDR Report Key: 17364144
• Report Number: 3014162263-2023-00019
• Device Sequence Number: 20140316
• Product Code: HCG
• UDI-Device Identifier: 00818053026706
• UDI-Public: 00818053026706
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/20/2023

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 Model Number: OPTI0208HSS10
• Device Catalogue Number: N/A
• Device Lot Number: F230400361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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