MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0102CSS10
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "physician was coiling off a shallow basilar reoccurrence.He was on his final coil, a 1 x2 optima complex super soft.The deployment went well.The optima was detached and the pusher was removed.Then doctor removed the catheter and the 1/2 of the coil was drug out by the micro catheter.With about 1 cm of the coil in the parent artery he decided to lay down another stryker atlas out the other pca branch.The patient is doing fine with no issues." 28jul2022, additional information provided - "no injury to the patient occurred.".
Additional Manufacturer Narrative
Balt usa reference number: (b)(4).Incident being reported due to the physician intervention performed during the procedure.The implant of the optima coil system was able to successfully deploy and detach within the treatment site.After the physician removed the microcatheter, the implant coil became herniated with half of the implant protruding out of the treatment location.With about 1cm of the implant coil protruding into the parent artery, the physician deployed a stent to tack down the herniated implant coil.No patient injury occurred as a result of the incident.Post-surgery, the patient was reported to be fine with no other issues.An evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.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 f220500777 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: 15294619
• Report Number: 3014162263-2022-00025
• Device Sequence Number: 6276918
• Product Code: HCG
• UDI-Device Identifier: 00818053025716
• UDI-Public: 00818053025716
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/19/2022

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: OPTI0102CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F220500777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2022
• 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