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

Model Number OPTI0408CSS10

Device Problem Device Fell (4014)

Patient Problem Aneurysm (1708)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

To whom it may concern: on (b)(6) 2019, balt usa received a complaint regarding the use of a single optima coil (4mm 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 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
• Type of Device: OPTIMA COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine 92618
• MDR Report Key: 9338895
• MDR Text Key: 169059481
• Report Number: 3014162263-2019-00019
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053021596
• UDI-Public: 00818053021596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: OPTI0408CSS10
• Device Catalogue Number: N/A
• Device Lot Number: 092619A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention