MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0152CSSMX
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).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 f201100091 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.
Event or Problem Description
It was reported that: "coil predetached in rhv and catheter.Due to challenges with the case the microcatheter could not be removed.Tried to push coil with another coil.Had to use a wire to advance the coil.While advancing coil into an, coil protruded through dome of an.After advancing whole coil in an, added more coils to achieve stasis." (b)(6) 2021 follow up (1): what is the status of the patient? pt was similar state after the procedure.Pt is stable.This was an incredibly sick patient prior to the procedure.Can you elaborate when you say the coil protruded through the dome of the aneurysm? does this mean that the aneurysm ruptured? second question, the coil ended up in the subarachnoid space however there was no extravasation of contrast.This was a second coiling of a pt that previously had a sah.The coil went through he dome but there was no extravasation of contrast.

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 12111900
• Report Number: 3014162263-2021-00024
• Device Sequence Number: 14602603
• Product Code: HCG
• UDI-Device Identifier: 00818053024955
• UDI-Public: 00818053024955
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: 11/09/2025
• Device Model Number: OPTI0152CSSMX
• Device Catalogue Number: N/A
• Device Lot Number: F201100091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 07/02/2021
• 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: Life Threatening