MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0310CSS10
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Codes	Stroke/CVA (1770); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2021
Type of Reportable Event	Malfunction
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 f200800002 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: "i was just informed of the issue in the case today.Thephysician was repairing a ruptured left pcomm aneurysm and was putting in his fourth optima coil a 3x10 csf.He was taking the coil in and out to reposition when he decided coil wasn't going where he wanted and began pulling coil out and it premature detached in the catheter.The coil inadvertently detached partially within the catheter and the anuerysm, basically the detachment zone broke.He lost the coil out the front of the catheter when he went to remove and the coil flew up the mca and caused a blockage in the artery.He was able to get past the coil and stent it along the vessel in place.Patient had some stroke like symptoms but has recovered.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 11638875
• Report Number: 3014162263-2021-00016
• Device Sequence Number: 16889536
• Product Code: HCG
• UDI-Device Identifier: 00818053025907
• UDI-Public: 00818053025907
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: 08/07/2025
• Device Model Number: OPTI0310CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F200800002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/08/2021
• 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