MAUDE Adverse Event Report: BLOCKADE MEDICAL BARRICADE COIL

Model Number 9000801137FR18

Device Problem Accessory Incompatible (1004)

Patient Problem Aneurysm (1708)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

The device was successfully implanted and the pusher was not returned for investigation.Without the device, a product investigation was not possible.Based on the complaint description alone, the definitive root cause of the 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 on (b)(6) 2016 while treatment with barricade coils, the coil prematurely detached and stretched.On 08/22/2017 letter received from (b)(6), with additional information.Event date: (b)(6) 2016, lot number: 021216a-080, part number: 900080.Event description: during deployment of the last coil the barricade complex frame 11mm x 37cm of the coil was only partially deployed within the cavernous sinus and spontaneously detached from the posterior wire due to a likely device malfunction.We then unsuccessfully attempted to push the remaining loose coil into the cavernous sinus with the echelon 10.We then attempted to flush the coil out of the microcatheter where it ended up lodged at the left internal jugular vein.The coil subsequently fell into the internal jugular vein down into the innominate vein into the superior vena cava at the svc right atrium junction.On 8/29/2017 additional information received; (b)(4) (blockade medical sales representative) spoke to dr.(b)(6) (treating physician) via phone call.Dr.(b)(6) confirmed the event from fda letter.Adding the following: patient was involved in a car accident.Patient was treated with blockade coils.Device malfunction and was lodged into the patients left internal jugular vein.

• Brand Name: BARRICADE COIL
• Type of Device: BARRICADE COIL
• Manufacturer (Section D): BLOCKADE MEDICAL; 18 technologies drive #169; irvine CA 92618
• Manufacturer Contact: charles yang ; 18 technology suite 104; irvine, CA 92656 ; 9497881443
• MDR Report Key: 6862158
• MDR Text Key: 86006237
• Report Number: 3009698517-2017-00001
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: 9000801137FR18
• Device Lot Number: 021216A-080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2012
• 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): Hospitalization