MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0620CST10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician was treating a case of a-com aneurysm procedure.The plan was to do simple coiling.He successfully got access and deployed two optima coils and during the 3rd coil deployment of 6x20cm, he found that coil got detached prematurely inside the micro catheter proximal to its length.He tried t0 took it out along with the micro catheter, but it didn't came out then he use a solitaire device to retrieve it and got success.He again placed the micro catheter inside the aneurysm and completed the procedure with other sizes of optima coils." (b)(6) 2023, additional information received from the issuer: "the procedure was continued without any injury.".
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.
Additional Manufacturer Narrative
Balt usa reference #(b)(4).The returned device was inspected in our quality laboratory.During our analysis: we noted the implant coil was returned detached from the delivery pusher; we observed signs of a detachment cycle performed at the detachment zone, with the pet jacket melted at the heater coil; we observed stretching at the body coil located 30mm proximal of the detachment zone for approximately 17mm, with the sr thread opaque in color; we observed a break point of the sr thread located approximately 43mm proximal of the detachment zone, with a tapered tip at the break point; we observed the implant coil to be severely stretched throughout, with 17cm unstretched from the distal end and a minor kink 11cm proximal of the distal tip; we observed a break point of the sr thread located approximately 17cm proximal of the implant coil's distal tip; we observed the hypotube to contain multiple bends throughout.Root cause of the reported premature detachment can likely be attributed to the implant coil enduring excessive tensile stress while being manipulated through the microcatheter.Upon return of the device, the detachment zone showed signs that a detachment cycle was performed, with the visual indication of the pet jacket being exposed to heat.The body coil was further assessed which revealed that the sr thread was broken within the body coil approximately 4cm proximal of the detachment zone, with a slightly tapered tip at the location of the break.Considering the break location and characteristics of the thread, it is likely that tensile overload led to the premature detachment of the implant coil.As the detachment zone showed signs of a detachment cycle being performed, this likely occurred following the premature detachment.It is unknown if the microcatheter used during the procedure contributed to the premature detachment, however this is unlikely if the same microcatheter was able to be used to place the succeeding coils following this incident.The implant coil was severely damaged upon return of the device, however it is unknown the extent of the damage sustained by the implant leading up to the premature detachment.If the implant were to have been damaged upon advancing through the microcatheter, this could have caused friction upon advancing the coil system and ultimately leading to the premature detachment.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 f220500506 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: "the physician was treating a case of a-com aneurysm procedure.The plan was to do simple coiling.He successfully got access and deployed two optima coils and during the 3rd coil deployment of 6x20cm, he found that coil got detached prematurely inside the micro catheter proximal to its length.He tried t0 took it out along with the micro catheter, but it didn't came out then he use a solitaire device to retrieve it and got success.He again placed the micro catheter inside the aneurysm and completed the procedure with other sizes of optima coils." 03apr2023, additional information received from the issuer: "the procedure was continued without any injury.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 16785974
• Report Number: 3014162263-2023-00011
• Device Sequence Number: 5554126
• Product Code: HCG
• UDI-Device Identifier: 00818053026324
• UDI-Public: 00818053026324
• 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): 06/16/2023

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: OPTI0620CST10
• Device Catalogue Number: N/A
• Device Lot Number: F220500506
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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