MAUDE Adverse Event Report: BALT USA, LLC BARRICADE; BARRICADE COIL

Model Number 900123

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Aneurysm (1708); Death (1802); Patient Problem/Medical Problem (2688)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

The barricade coil was not received for evaluation, as it was implanted.Therefore; and analysis could not be performed.Based on the available information the root cause of this complaint could not be determined.Review of the lot history records for the reported lot did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against the reported lot have been made for the same issue.

Event Description

It was reported that a "coil was prepared as per the ifu and pushed inside micro catheter.Barricade complex finish 5x8 coil was deployed in atom aneurysm.After complete coil deployment physician waited for 10 minutes to take check shoot before detachment.In check shoot it was observed that opposite a2 was not filling so physician decided to retrieve the coil.While retrieving coil it got prematurely detached inside micro catheter.Coil was left like that & case was abandoned since 70% of coil remained inside aneurysm & 30% in vessel.Patient kept on ventilator post case".

Manufacturer Narrative

The barricade coil was not received for evaluation, as it was implanted.Therefore, an analysis could not be preformed.Based on the provided information, root cause could not be definitively determined.Review of the lot history records for the reported lot did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against the reported lot have been made for the same issue.

Event Description

It was reported that a "coil was prepared as per the ifu and pushed inside micro catheter.Barricade complex finish 5x8 coil was deployed in atom aneurysm.After complete coil deployment physician waited for 10 minutes to take check shoot before detachment.In check shoot it was observed that opposite a2 was not filling so physician decided to retrieve the coil.While retrieving coil it got prematurely detached inside micro catheter.Coil was left like that & case was abandoned since 70% of coil remained inside aneurysm & 30% in vessel.Patient kept on ventilator post case.".

• Brand Name: BARRICADE
• Type of Device: BARRICADE COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• Manufacturer Contact: charles yang ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 7744112
• MDR Text Key: 115841561
• Report Number: 3009698517-2018-00009
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053021220
• UDI-Public: 00818053021220
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K151760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2020
• Device Model Number: 900123
• Device Catalogue Number: 900123
• Device Lot Number: 120315A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2018
• 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): Death; Required Intervention