MAUDE Adverse Event Report: BALT USA, LLC OPTIMA COIL SYSTEM

Model Number	OPTI0508CSS10
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To whom it may concern: on (b)(6) 2019, balt usa received a complaint regarding the use of a single optima coil (5mm x 8cm complex super soft).Details reported as follows: "treating a 6x5 sca aneurysm with balloon assist.5x8 ccs was second coil detached with balloon assist.The physician took down the balloon and when re-inflating the balloon it sailed pulling on the micro catheter.The physician repositioned the microcatheter and placed a 4x8 ccs.When the physician went down and back up with balloon the final 2mm of both the 5x8 and 4x8 coils popped out of the aneurysm and into the parent artery.The physician had to place a lvis jr stent to cover." the results of our investigation following return of the affected device, are summarized as follows: an evaluation of the actual complaint sample could not be performed device was reported unavailable.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 for the reported lots did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number 092419a 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: "treating a 6x5 sca aneurysm with balloon assist.5x8 ccs was second coil detached with balloon assist.The physician took down the balloon and when re-inflating the balloon it sailed pulling on the micro catheter.The physician repositioned the microcatheter and placed a 4x8 ccs.When the physician went down and back up with balloon the final 2mm of both the 5x8 and 4x8 coils popped out of the aneurysm and into the parent artery.The physician had to place a lvis jr stent to cover.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 9338863
• Report Number: 3014162263-2019-00018
• Device Sequence Number: 1873445
• Product Code: HCG
• UDI-Device Identifier: 00818053021619
• UDI-Public: 00818053021619
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: 08/01/2021
• Device Model Number: OPTI0508CSS10
• Device Catalogue Number: N/A
• Device Lot Number: 092419A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/18/2019
• 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