MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number NOT REPORTED

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

Balt usa's reference number: (b)(4).To whom it may concern: on september 30, 2020, balt usa has been notified of an event regarding the use of a single optima coil.Details reported as follows: "anevrismal reliquate." 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.The lot number was not provided therefore; a review of the lot history records could not be performed.

Event Description

It was reported: "anevrismal reliquate.".

• 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: 10734434
• MDR Text Key: 213048732
• Report Number: 3014162263-2020-00034
• Device Sequence Number: 1
• Product Code: HCG
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT REPORTED
• Device Lot Number: NOT REPORTED
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization