MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0417CSF10
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during deployment of the coil into the aneurysm, a detach occurred.When the pusher was removed stretching occurred." incident report form submitted for the complaint file indicates that no patient injury was sustained.12sep2022, additional information received from the issuer: "did the coil prematurely detach in the treatment site or in the microcatheter? we were told it occurred in the microcatheter (detaching sound was heard).Were any additional procedures performed to retrieve the coil? procedure to remove the coil with snare was performed.".
Additional Manufacturer Narrative
Balt usa reference # (b)(4).Initial notification of the incident received on 07sep2022.The results of the reportability evaluation on 07sep2022 deemed this event as not reportable.Additional information received from the issuer on 12sep2022, which resulted in the reportability evaluation deeming this event as reportable.The returned device was inspected in our quality laboratory.During our analysis: we noted that the associated snare was returned protruding out of the distal end of another microcatheter; we noted that the hub of the returned microcatheter was cut off and not returned; we observed minor kinks along the distal end of the returned microcatheter; we observed the implant to be severely stretched within the returned microcatheter - the implant was unable to be retrieved; we observed 4cm of the stretched coil to be protruding from the microcatheters distal end; we observed 2 minor kinks along the returned delivery pusher, located 3cm and 13.5cm proximal of the delivery pusher's distal end; we observed visual damage to the detachment zone, with the green lead wire bent but the solder joints intact; we observed the sr thread to be protruding out of the detachment zone and opaque in color.Root cause of the reported premature detachment can be attributed to an overload in tensile stress exerted on the implant coil.Upon device return, the implant was stretched throughout and stuck within the returned microcatheter, with approximately 4cm of the stretched coil to be protruding out the microcatheters distal end.The implant was returned detached from its delivery pusher and damage was observed at the detachment zone, with the green lead wire bent but the solder joints intact.Additionally, 2 minor kinks were observed along the delivery pusher, located 3cm and 13.5cm proximal of the delivery pusher's distal end.Device analysis showed the sr thread to be broken and opaque in color, an indication that the sr thread endured tensile overload during coil retraction.It is unknown if the implant was damaged during the use of the coil system.If the implant had become damaged during the use of the coil system, advancement of the damaged implant could have caused friction through the microcatheter, possibly leading to the premature detachment and coil stretching upon retraction.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 f201000442 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: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 15579983
• Report Number: 3014162263-2022-00031
• Device Sequence Number: 6470155
• Product Code: HCG
• UDI-Device Identifier: 00818053026126
• UDI-Public: 00818053026126
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 10/04/2022

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 Expiration Date: 10/21/2025
• Device Model Number: OPTI0417CSF10
• Device Catalogue Number: N/A
• Device Lot Number: F201000442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2020
• 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