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

Model Number	OPTI0154CSS10
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To whom it may concern: on march 13, 2020, balt usa received a complaint regarding the use of a single optima coil (1.5mm x 4cm complex super soft).Details reported as follows: "during removal of micro-catheter, migration of the last coil complex-10 super soft." the results of our investigation, are summarized as follows: an evaluation of the actual complaint sample could not be performed as the device was reported unavailable.Follow up was made and it was reported that the deficiency did not lead to death or serious deterioration in health of the patient.It is possible that a combination of coil placement and interaction with other devices at the treatment site led to migration of the optima coil; however, lack of device return prevented deeper evaluation of the reported issue.Review of the lot history record 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 041719a 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: "during removal of micro-catheter, migration of the last coil complex-10 super soft.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine, ca
• MDR Report Key: 9944318
• Report Number: 3014162263-2020-00007
• Device Sequence Number: 19647680
• Product Code: HCG
• UDI-Device Identifier: 00818053025761
• UDI-Public: 00818053025761
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2020

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: 04/01/2021
• Device Model Number: OPTI0154CSS10
• Device Catalogue Number: N/A
• Device Lot Number: 041719A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/09/2020
• 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