MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0307CSSMX
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
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 no visual damage to the detachment zone, with the pet jacket and lead wires intact; we observed the implant to be severely stretched throughout with the distal 33mm of the implant unstretched but containing multiple kinks throughout; we observed the sr thread on the distal end of the implant coil to be severely stretched and opaque in color (i.E white); we observed a minor kink on the hypotube 23cm proximal of the hypotube and body coil weld; we observed the sr thread to be broken 3mm proximal of the detachment zone and opaque in color with a slight taper at the break location; we observed minor visual damages to the distal tip of the introducer sheath.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.Upon return of the device, the coil was observed to be detached from its delivery pusher.Device investigation showed no visual damage to the endured some damages during the repositioning of the coil, however this cannot be confirmed.Attempts made to advance the coil system while encountering advancement issues can cause further damage to the implant.It is unknown if the microcatheter associated with the incident was damaged, possibly causing friction during advancement attempts and contributing to the reported premature separation.Further confirmation of tensile overload was made by extracting the sr thread from the delivery pusher, and observing a slight taper to the break location of the thread.In addition, it is likely that the stretched portion of the implant coil was a result of the user utilizing a snare to retrieve the implant coil.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 f230100220 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: "neuron max 90cm, sl10 45 degree mc parallel with a scepter xc 4x11.The plan was to do a balloon assisted coiling of a wide neck spherical aneursym on the ica.Initially framed with a 4x7 optimax soft complex along with balloon assistance.The frame set and deployed without any issues.The following coil was a 3x7 optimax supersoft complex and as the initial phases of deployment was initiated, a little resistance was felt by the fellow when the balloon was up.The attending physician took over and tried to advance and pull back as the coil was not sitting right.As soon as he attempted that maneuver, he lost 1:1 control and the coil prematurely detached with it partially in the sl10 45 degree microcatheter.Careful removal of the sl10 45 degree was attempted, however the 3x7 optimax coil flipped out and migrated into the mca.As a result, the physician had to snare the the coil out of the mca and was able to safely remove the 3x7 optimax while keeping the framed coil (4x7 optimax soft).The case was concluded after removal of the 3x7 optimax supersoft and the patient is doing well.".

• 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: 16702315
• Report Number: 3014162263-2023-00009
• Device Sequence Number: 17063191
• Product Code: HCG
• UDI-Device Identifier: 00818053025044
• UDI-Public: 00818053025044
• 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): 04/03/2023

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: OPTI0307CSSMX
• Device Catalogue Number: N/A
• Device Lot Number: F230100220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2023
• 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