MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI1265BLK

Device Problems Migration (4003); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2023

Event Type  malfunction  

Event Description

It was reported that: "physician was advancing coil into a fistual pouch.The coil prematurely detached.There was an extremely long tail (approximately 15-20cm) of coil still left in the mma.Physician had to pull out the microcatheter, access the fistula alongside the detached coil to continue.We were able to finish the case.Unable to send back pusher as was destroyed and trashed before i could grab it." incident report form submitted for this complaint indicates that no patient injury was sustained.

Manufacturer Narrative

Balt usa reference (b)(4).An evaluation of the actual complaint sample could not be performed as device was unavailable to be 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 records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f230400199 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.

• Brand Name: OPTIMA COIL SYSTEM
• Type of Device: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 18617193
• MDR Text Key: 334264317
• Report Number: 3014162263-2024-00001
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810068568844
• UDI-Public: (01)00810068568844(11)230410(17)280410(10)F230400199
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2023
• Device Model Number: OPTI1265BLK
• Device Lot Number: F230400199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• 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): Other