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

Model Number	900123
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Patient Problem/Medical Problem (2688)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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".
Additional 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 or Problem 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
• Common Device Name: BARRICADE COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 7744112
• Report Number: 3009698517-2018-00009
• Device Sequence Number: 19229768
• Product Code: HCG
• UDI-Device Identifier: 00818053021220
• UDI-Public: 00818053021220
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention