MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0202CSS10

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Rupture (2208)

Event Date 08/29/2020

Event Type  malfunction  

Manufacturer Narrative

Balt usa's reference number: (b)(4).To whom it may concern: on (b)(6) 2020, balt usa has been notified of an event regarding the use of a single optima coil.Details reported as follows: "intra-operative aneurysm rupture." an evaluation of the actual complaint sample could not be performed as the device was unavailable for return.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 record did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number 052119a 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 Description

It was reported: "intra-operative aneurysm rupture.".

• Brand Name: OPTIMA COIL SYSTEM
• Type of Device: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine 92618
• MDR Report Key: 10570820
• MDR Text Key: 209994512
• Report Number: 3014162263-2020-00020
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053021442
• UDI-Public: 00818053021442
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: OPTI0202CSS10
• Device Catalogue Number: N/A
• Device Lot Number: 052119A
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• 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): Life Threatening; Required Intervention