MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0204CSS10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).Pending device return.
Event or Problem Description
It was reported that: "during coil deployment, pre-detach defect of unknown cause occurred.During coil delivery, friction was not detected, and the coil detached while removing with the snare.So for safety, one more stent was deployed on the location of the coil.".
Event or Problem Description
It was reported that: "during coil deployment, pre-detach defect of unknown cause occurred.During coil delivery, friction was not detected, and the coil detached while removing with the snare.So for safety, one more stent was deployed on the location of the coil.".
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).The returned device was inspected in our quality laboratory.During our analysis: we observed the microcatheter to be returned with the delivery pusher, but the microcatheter hub has been broken off; we observed the detachment zone to be free of any visual damage including the lead wires and solder joints being intact; we noted the delivery pusher had several severe kinks proximal of the last warning stripe; we noted an in-house guidewire would no longer advance through the microcatheter approximately 104cm from microcatheter's proximal end; we noted after cutting open the returned microcatheter, the blockage was due to dried blood.Root cause of the premature detachment cannot definitively be determined.During our investigation, we noted the delivery pusher was returned in addition to the microcatheter used during the incident, however the hub of the microcatheter was broken off of the proximal end.Without the hub of the microcatheter, an in-house coil system could not be tested through therefore an in-house guidewire was ran through the microcatheter.The severe kinks found along the delivery pusher were likely caused from the user attempting to retract the coil system from the microcatheter.It is possible that the implant became caught on a secondary device at the treatment site and the premature detachment was the result of the unintentional interaction.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 f191200070 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
• MDR Report Key: 11638849
• Report Number: 3014162263-2021-00015
• Device Sequence Number: 14302092
• Product Code: HCG
• UDI-Device Identifier: 00818053021466
• UDI-Public: 00818053021466
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 12/13/2021
• Device Model Number: OPTI0204CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F191200070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention