MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0620CSFMX
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference number: #(b)(4).The returned device was inspected in our quality laboratory.During our analysis: we noted that the snare associated with the incident was returned; we noted that the microcatheter associated with the incident was returned; we noted that the returned microcatheter was cut at the microcatheter hub (hub not returned); we observed no damage along the returned portion of the microcatheter; we noted that the delivery pusher was not returned; we observed the sr thread to be protruding out of the implant's proximal end and measuring 5cm in length; we observed the sr thread to be opaque in color, indicating that is has been stretched; we observed the coil to be crushed and kinked located 4cm, 7cm, and 7.5cm distal of the implant's proximal end; we observed the coil to be stretched and severely kinked 2cm proximal of the implant's distal end.Root cause of the premature detachment endured by the coil system cannot be definitively determined, however it is evident that the implant coil had endured tensile overload, possibly causing the premature detachment.Upon return of the device, the coil was observed to be detached from its delivery pusher, with approximately 5cm of the sr thread protruding out of the implant's proximal end.Device investigation showed damage to the implant, with the coils crushed and kinked in 3 different locations: 4cm, 7cm, and 7.5cm distal of the implant's proximal end.Moreover, the coil was observed to be stretched and severely kinked 2cm proximal of the implant's distal end.It is possible that the sr thread was overhandled during the attachment process of the implant to the pusher leading to the decreased tensile strength. the manufacturing procedure calls for (b)(4) inspection for damage to the sr thread prior to loading the implant coil into the delivery pusher.Since the delivery pusher was not returned, it is unknown whether the delivery pusher sustained kinks or if the detachment zone was damaged, which could have contributed to the reported issue.It was reported that the returned coil was the 12th coil used during the procedure.Unwanted interaction with other coils could have caused damaged to the reported implant, thereby causing friction upon retraction.The sr thread was observed to be opaque in color, indicating that the thread was stretched prior to the premature detachment that occurred during coil removal.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 f220400250 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: "physician had a premature detachment of a 6x20 optimax complex soft.Using an echelon 10 the physician deployed 11 deployed coils into a facial avm.On the 12th coil he tried repositioning the 6x20 several times due to it not being the right size.Upon removal, the coil prematurly detached.The physician removed the catheter and retrieved coil with snare, safely removing it from the vessel.No patient injury occured.I have product available for return.Looks like the snare is also included in return package.".

• 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: 15651413
• Report Number: 3014162263-2022-00032
• Device Sequence Number: 2381437
• Product Code: HCG
• UDI-Device Identifier: 00818053025211
• UDI-Public: 00818053025211
• 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
• Report Date (Section B): 10/17/2022

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: OPTI0620CSFMX
• Device Catalogue Number: N/A
• Device Lot Number: F220400250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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