MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0724CSF10
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference #(b)(4).An evaluation of the actual complaint sample could not be performed as device was unavailable to be 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 f210500198 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: "ruptured acom lobulated aneurysm was coiled, microcatheter vasco+10 was used, firstly the small doughter sac was coiled with supersoft coil 4*6 mm and the microcatheter wass pulled back to the main sac of the aneurysm, first fraiming coil and second filing coils were inserted uneventually with one repositioning maneuver of the second coil due to loop protrusion, then the third coil complex-10 soft 7mm *24 cm was inserted smoothly and due to coil protrusion to the parent artery right aca after inserting 2/3 of the coil an effort made to reposition the coil, after pulling about one centimeter of the coil, the coil detached in the microcatheter, fortunatly i was able to push it back totally with the coil pusher in to the aneurysm sac with no protrusion.The microcatheter removed from the aneurysm smoothly." incident report form submitted for this complaint indicates that no patient injury was sustained.

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer (Section G): BALT USA; 29 parker; irvine 92618
• Manufacturer Contact: david vu ; 29 parker; irvine 92618 ; 9497881443
• MDR Report Key: 18165445
• Report Number: 3014162263-2023-00068
• Device Sequence Number: 6503573
• Product Code: HCG
• UDI-Device Identifier: 00818053026218
• UDI-Public: 00818053026218
• Combination Product (Y/N): N
• Initial Reporter Country: IZ
• PMA/510(K) Number: K223386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2023

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 Expiration Date: 05/20/2026
• Device Model Number: OPTI0724CSF10
• Device Lot Number: F210500198
• 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: 10/18/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown