MAUDE Adverse Event Report: BLOCKADE MEDICAL BARRICADE COIL

Model Number	900116
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The barricade complex finish coil was received for evaluation.Visual analysis revealed the delivery pusher within the packaging hoop.The delivery pusher was found with the implant coil detached, the implant coil was not returned.The detachment zone section exhibited the stretch resistance thread unwound from the attachment bond.Stretch resistance thread shows striations and white opaque segments consistent with elongating.Based on the available information and the evaluation findings the reported complaint is not confirmed as the implant coil is not returned.The actual root cause of this complaint cannot be determined; as the complaint device implant was not returned.However; the condition of the returned device pusher is consistent with resistance during retraction exposing the device to a force that exceeds tensile specifications.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 during treatment with barricade coil, "while taking coil into aneurysm, the physician had to withdraw a loop of the coil in order to that in into desired portion of aneurysm sac, but instead of coil coming out with a slight pull, it got stretched and became as a thread.As the physician was struggling to pull out the entire coil out, it got detached with distal 2 loops in the aneurysm and rest coil hanging proximally.Then, finally physician decide to retrieve the entire coil with the help of stent retriever.After the complete retrieval the procedure was done with other size of the coil.".

• Brand Name: BARRICADE COIL
• Common Device Name: BARRICADE COIL
• Manufacturer (Section D): BLOCKADE MEDICAL; 18 technology drive #169; irvine CA 92618
• MDR Report Key: 7291209
• Report Number: 3009698517-2018-00002
• Device Sequence Number: 14028742
• Product Code: HCG
• UDI-Device Identifier: 00818053021152
• UDI-Public: 00818053021152
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

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: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 900116
• Device Catalogue Number: 900116
• Device Lot Number: 101817B-116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2018
• 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