MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX DETACHABLE; EMBOLIZATION COIL

Model Number	45-780516
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device has not been returned to the manufacturer; therefore, a product analysis could not be performed.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that after repeated attempts to reposition an embolization coil in the gastroduodenal artery, the coil detached inside the microcatheter.The detached coil was removed in its entirety with a snare device without incident.There was no reported patient injury.The patient was reported to be stable.
Additional Manufacturer Narrative
The pusher, introducer, implant coil, and guidewire were returned.The dispenser hoop and microcatheter were not returned.The returned pusher was stuck inside the indroducer.The introducer was flushed with a saline solution in order to move the pusher.The introducer was trimmed to review the distal section of the pusher, including the attachment area.The monofilament was attached to the marker band section and was broken next to the attachment area.The implant coil had blood residues and it was kinked.Based on the physical evaluation of the returned device, the reported complaint is confirmed.The returned coil system was found to be heavily damaged, which likely occurred during the removal of the implant after it prematurely detached as described in the reported complaint.The attachment monofilament was found to be broken, which indicates the implant detached due to tensile force and not from a normal thermal detachment.The physical evaluation of the coil system could not identify the cause of the force, though this force can occur when the coil becomes stuck or experiences friction in the microcatheter, and the user attempts to retract the coil with enough force to overcome the strength of the monofilament.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8438086
• Report Number: 2032493-2019-00058
• Device Sequence Number: 19345833
• Product Code: KRD
• UDI-Device Identifier: 00810170018305
• UDI-Public: (01)00810170018305(11)180409(17)230331(10)1804095W3
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

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: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 45-780516
• Device Catalogue Number: 45-780516
• Device Lot Number: 1804095W3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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