MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0611CSF10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference (b)(4).Investigation pending the return of the suspected device for analysis.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: "the physician planned to do aneurysm case.The plan was to use optima coils.After getting access of the guiding catheter then took the vasco10mp & hybrid1214d position into to the aneurysm and removed the wire.The physician took optima complex soft 6x11 for first coil.The physician deploying the coil off of the coil deploying after that reposition the coil but unable do it and coil was prematurely deployed into the microcatheter.The physician took stent retriever and removed the coil.The physician took another optima coil and followed by took 4 more coils finished the case.The case went off well and the patient is fine." incident report form submitted for this complaint indicates that no patient injury was sustained.
Event or Problem Description
It was reported that: "the physician planned to do aneurysm case.The plan was to use optima coils.After getting access of the guiding catheter then took the vasco10mp & hybrid1214d position into to the aneurysm and removed the wire.The physician took optima complex soft 6x11 for first coil.The physician deploying the coil off of the coil deploying after that reposition the coil but unable do it and coil was prematurely deployed into the microcatheter.The physician took stent retriever and removed the coil.The physician took another optima coil and followed by took 4 more coils finished the case.The case went off well and the patient is fine." 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 observed the implant coil to be severely stretched and kinked; - we observed the sr thread near the distal tip of the implant to have experienced necking - indicating the thread endured an overload in tensile stress; - we observed major kinks along the hypotube, approximately 1mm, 8cm, 11cm and 30.5cm distal from the gold connector; - we observed major kinks along the hypotube, approximately 5cm, 8cm, 10.5cm and 18cm proximal from the body coil weld; - we observed minor kinks along the introducer sheath, approximately 48cm and 48.5cm distal from the proximal end; - we observed no damages to the detachment zone with the pet jacket, lead wire and solder joints intact; - we conducted destructive testing of the delivery pusher to reveal the detachment profile of the sr thread; - we observed the tip of the sr thread within the detachment zone experienced necking - indicating the thread endured an overload in tensile stress.Root cause of the premature detachment endured by the coil system can likely be attributed to an overload of tensile stress endured by the sr thread, possibly caused by friction encountered when attempting to retract the coil system.Upon device return, we observed major and minor kinks along the hypotube and introducer sheath as well the implant coil to be severely stretched and kinked.In addition, we observed the sr thread near the distal tip of the implant and within detachment zone to have experienced necking, indicating the thread endured an overload of tensile stress.It was reported the physician was deploying the coil and tried to reposition the coil, but was unable do it.Then, the implant prematurely deployed into the microcatheter.From our observations, it's possible the implant was damaged during advancement which led to the multiple kinks found along the coil system.It is likely premature detachment was caused when retracting the implant.If the microcatheter had become ovalized during the procedure, this could have led to the coil system encountering friction and further leading to the premature detachment.However, without the return of the microcatheter, this cannot be confirmed.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 complaints against lot number f210500108 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 ; 9497881443
• MDR Report Key: 17455441
• Report Number: 3014162263-2023-00021
• Device Sequence Number: 2686320
• Product Code: HCG
• UDI-Device Identifier: 00818053026171
• UDI-Public: 00818053026171
• 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,Followup
• Report Date (Section B): 07/28/2023

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 Expiration Date: 05/12/2026
• Device Model Number: OPTI0611CSF10
• Device Lot Number: F210500108
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (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