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

Model Number	OPTI1027CST10
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Aneurysm (1708); Patient Problem/Medical Problem (2688)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To whom it may concern: on (b)(6) 2018, we received a complaint regarding the use of a single optima coil (10mm x 27cm complex standard coil)."during embolisation, the coil "made" a node, and was unable to be retrieved, the coil detached spontaneously during retrieval of mc / coil system.A stent retriever was used to retrieve the coil.Another one was used." the results of our investigation following return of the affected device, are summarized as follows: the optima complex standard coil investigation revealed the delivery pusher with the implant coil not attached.The detachment section pet was intact.The sr thread that holds the implant coil attached to the pusher coil was found fractured distal to the attachment zone.The end of the sr thread has an appearance of being stretched.Without inspection of the implant, further investigation of the product issue is not possible.Based on the provided information and the investigations results the reported complaint was confirmed as the coil was detached from the pusher, it is possible that the implant coil was exposed to a force that exceeds tensile specifications however, without the implant coil the root cause cannot be determined.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 121417b have 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: "during embolisation, the coil "made" a node, and was unable to be retrieved, the coil detached spontaneously during retrieval of mc / coil system.A stent retriever was used to retrieve the coil.Another one was used.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 8167196
• Report Number: 3009698517-2018-00015
• Device Sequence Number: 2792462
• Product Code: HCG
• UDI-Device Identifier: 00818053021916
• UDI-Public: 00818053021916
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/30/2018

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: 12/14/2019
• Device Model Number: OPTI1027CST10
• Device Lot Number: 121417B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/14/2018
• 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