MAUDE Adverse Event Report: BALT USA, LLC BARRICADE COIL

Model Number	900013
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The barricade coil was not received for evaluation.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 "1mm x 1cm complex finish coil was used as 2nd coil under the balloon assisted but the coil could not be detached though the surgeon tried detachment at 3 times.Then, the coil was removed and other coil of the same size was used and detached and placed in properly.It was reported that the coil (maybe barricade coil) was migrated to near mca (m3) unintentionally and the bleeding was also observed at m2 segment during withdrawing the migrated coil (subarachnoid hemorrhage was developed).Third coil (barricade coil) was detached properly after the surgeon inserted the needle deeper.Therefore, the surgeon guess that the depth of the needle might have resulted in this detachment error.The surgeon also commented that there is no relation between detachment error and migration of the coil.(3rd coil might had not got twine around with 1st coil enough).".

• Brand Name: BARRICADE COIL
• Common Device Name: BARRICADE COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 7495676
• Report Number: 3009698517-2018-00005
• Device Sequence Number: 18891928
• Product Code: HCG
• UDI-Device Identifier: 00818053020148
• UDI-Public: 00818053020148
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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
• Operator of Device: No Information
• Device Expiration Date: 05/01/2022
• Device Model Number: 900013
• Device Catalogue Number: 900013
• Device Lot Number: 061517A-430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/08/2018
• 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: Required Intervention