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

Model Number	OPTI0620CSF10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/19/2019
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 (6mm x 20cm complex soft coil).Details reported as follows: "the physician deployed a 6x20 complex soft coil in an aneurysm and repositioned numerous times.When he decided it was not the right fit, he pulled out the coil system and the coil prematurely detached from pusher wire.He safely retrieved the coil with the comaneci stent system.There were no complications due to this premature detachment.The coil was removed safely.No other anomalies were observed.He continued to coil the aneurysm and successfully deployed 6 optima coils in the aneurysm.Patient suffered no consequences.Microcatheter was sl-10.No device to return." 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 092819b 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: "the physician deployed a 6x20 complex soft coil in an aneurysm and repositioned numerous times.When he decided it was not the right fit, he pulled out the coil system and the coil prematurely detached from pusher wire.He safely retrieved the coil with the comaneci stent system.There were no complications due to this premature detachment.The coil was removed safely.No other anomalies were observed.He continued to coil the aneurysm and successfully deployed 6 optima coils in the aneurysm.Patient suffered no consequences.Microcatheter was sl-10.No device to return.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 9589203
• Report Number: 3014162263-2020-00001
• Device Sequence Number: 19680471
• Product Code: HCG
• UDI-Device Identifier: 00818053021770
• UDI-Public: 00818053021770
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: OPTI0620CSF10
• Device Catalogue Number: N/A
• Device Lot Number: 092819B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/14/2020
• 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