MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0830CSFMX

Device Problems Stretched (1601); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2024

Event Type  malfunction  

Event Description

It was reported that: " sex: unknown disease name: 10mm an in ic-top procedure: emergency procedure micro catheter: sl-10/stryker assist stent: unknown y connector: unknown used coils: optimax, 2 targetxcel/stryker after placing 1 optimax coil and 2 targetxcel coils, the physician inserted optimax 8×30(reported coil).The physician performed several attempts of repositioning.After repeated attempts, the physician found that, despite he operated delivery wire the implant coil(the tip of it was placed in the target lesion) did no move no longer.It turned out that the implant coil got unraveled and retrieving attempt with snare were difficult.Eventually, the implant coil was torn off and partially remained in the aneurysm and some part of filament remained in the mother vessel.After that the procedure was continued with competitive coils and the loop of coil has been pushed out of the aneurysm.Thus the physician completed procedure by jacking up the stent and holding down part of the optimax strand with the stent, although it was a sah.It is unknown whether the physician performed before use check or not." incident report form submitted for this complaint indicates that no patient injury was sustained.

Manufacturer Narrative

Balt usa reference (b)(4).Investigaiton pending the return of the complaint 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 Description

It was reported that: " sex: unknown.Disease name: 10mm an in ic-top.Procedure: emergency procedure.Micro catheter: sl-10/stryker.Assist stent: unknown.Y connector: unknown.Used coils: optimax, 2 targetxcel/stryker. after placing 1 optimax coil and 2 targetxcel coils, the physician inserted optimax 8×30(reported coil).The physician performed several attempts of repositioning.After repeated attempts, the physician found that, despite he operated delivery wire the implant coil(the tip of it was placed in the target lesion) did no move no longer.It turned out that the implant coil got unraveled and retrieving attempt with snare were difficult.Eventually, the implant coil was torn off and partially remained in the aneurysm and some part of filament remained in the mother vessel.After that the procedure was continued with competitive coils and the loop of coil has been pushed out of the aneurysm.Thus the physician completed procedure by jacking up the stent and holding down part of the optimax strand with the stent, although it was a sah.It is unknown whether the physician performed before use check or not." incident report form submitted for this complaint indicates that no patient injury was sustained.

Manufacturer Narrative

Balt usa reference #(b)(4).The returned device was inspected in our quality laboratory.During our analysis: - we observed only the implant coil was returned; - we observed severe stretching along the implant, approximately 9cm proximal from the distal end; - we observed the sr thread within the implant coil to be opaque in color; - we observed the distal tip of the implant coil to be broken.Root cause of the reported issue endured by the coil system cannot definitively be determined due to the incomplete device return, however it is evident that the implant coil had become stretched and further prematurely detached from the delivery pusher.Upon device return, we observed severe stretching along the implant and the sr thread within the implant coil to be opaque in color, confirming that the implant coil had become stretched.The user reported that after multiple attempts to try to reposition the implant coil, it was discovered that the implant coil would no longer move when the delivery pusher was manipulated.During the procedure, a snare device was required to attempt to retrieve the device, however attempts served unsuccessful and resulted in the implant coil becoming broken.The procedure was concluded with an additional stent placed in order to secure the broken portion of the implant coil.The exact cause of the premature detachment cannot be determined without the delivery pusher and associated microcatheter used during the incident.If the implant coil were to have become damaged, this can lead to excessive friction being applied to the implant coil while it is moving through the microcatheter, which can cause the implant coil to prematurely detach.Moreover, if the microcatheter used during the incident had become damaged, this could have led to the reported issue by causing friction when advancing and retracting the coil system.A review of the lhr indicated that the unit was free from visual damage, including the implant coil at the point of the 100% 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 f231100305 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
• Type of Device: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 18741638
• MDR Text Key: 335813206
• Report Number: 3014162263-2024-00005
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053025259
• UDI-Public: (01)00818053025259(11)231108(17)281108(10)F231100305
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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
• Device Operator: Health Professional
• Device Model Number: OPTI0830CSFMX
• Device Lot Number: F231100305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 01/21/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention