MAUDE Adverse Event Report: BALT USA, LLC BARRICADE COIL

Model Number	900116
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The barricade coil has not yet been received for evaluation.Therefore; and analysis could not be performed.Upon return of the device an evaluation will be performed and follow up report will be submitted.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 "3mm x 10cm complex finish coil was inserted into the area of d-avf by using sl-10 but coil size was unappropriated and the surgeon tried to withdraw the coil.However, the pusher wire got stuck and could not be moved.The surgeon cut the pusher wire together with the hub of sl-10 by scissors, then attached the snare and pull out but the coil was unintentionally detached on the halfway.Then, the detached coil was placed within the patient and sl-10 was removed.".
Event or Problem Description
It was reported that a "3mm x 10cm complex finish coil was inserted into the area of d-avf by using sl-10 but coil size was unappropriated and the surgeon tried to withdraw the coil.However, the pusher wire got stuck and could not be moved.The surgeon cut the pusher wire together with the hub of sl-10 by scissors, then attached the snare and pull out but the coil was unintentionally detached on the halfway.Then, the detached coil was placed within the patient and sl-10 was removed.".
Additional Manufacturer Narrative
The barricade coil was received for evaluation.Results revealed the delivery pusher fractured at the zebra mark location as described by the customer.The implant coil was not attached to the distal end of the delivery pusher, the adhesive segment at the detachment zone on the pusher has the appearance of the coil being pulled out.The implant coil was not returned as it was implanted in the patient.Based on the available information and the investigation results the reported complaint was confirmed.The root cause of this complaint cannot be determined; however, it is possible by the condition of the pusher that the coil was stretched and sequentially exposed to a force greater than the tensile strength of the strech resistance thread resulting in fracture of the thread.The fracture of the thread may subsequently lead to the separation of the implant coil from the pusher.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.

• Brand Name: BARRICADE COIL
• Common Device Name: BARRICADE COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 7495737
• Report Number: 3009698517-2018-00006
• Device Sequence Number: 194764
• Product Code: HCG
• UDI-Device Identifier: 00818053020124
• UDI-Public: 00818053020124
• 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,Followup
• Report Date (Section B): 07/23/2018

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: 02/01/2022
• Device Model Number: 900116
• Device Catalogue Number: 900116
• Device Lot Number: 030817B-116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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