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

Model Number	45-751632
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.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 root cause is unknown 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 during the treatment of a right internal iliac aneurysm, the coil could not advance more than 5cm into the aneurysm.When the coil was withdrawn, the pusher was found to be detached.It was attempted to push the coil into the aneurysm with the pusher wire, but it would not advance.The entire coil was removed with the catheter.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.The investigation is ongoing.
Additional Manufacturer Narrative
Multiple devices were received, and the one relevant to the complaint was identified by labeling that matched the complaint information.A terumo microcatheter and a dynamics microcatheter were also received.The implant coil was received in a zip-lock bag; it was stretched at the proximal section, the gel was broken and the monofilament was not present at proximal section.The unit was returned without the pusher.No damages were found on the returned microcatheters.The reported complaint is non-verifiable based on the physical evaluation of the returned device.The coil was returned with labeling that matches the complaint information, but the physical evaluation of the coil itself cannot confirm with certainty that this is the coil related to the complaint.Based on the visual analysis of the other returned devices, the coil detailed in the analysis provided was determined to be the device most likely associated with the complaint.The damage to the device is consistent with the coil experiencing forces over specification, leading to the separation via a tensile break.The visual analysis of the device cannot determine the exact circumstances that led to the detachment, and since the pusher was not returned, the type of detachment cannot be verified.It is likely that the coil experienced friction during the procedure as described and detached during retraction, but the visual analysis of the coil cannot determine the cause for the friction.

• 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: 8656774
• Report Number: 2032493-2019-00150
• Device Sequence Number: 14119077
• Product Code: KRD
• UDI-Device Identifier: 00812636021096
• UDI-Public: (01)00812636021096(11)180418(17)230331(10)18041853F
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• 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,Followup
• Report Date (Section B): 05/01/2019

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: 03/31/2023
• Device Model Number: 45-751632
• Device Catalogue Number: 45-751632
• Device Lot Number: 18041853F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 05/01/2019; 05/01/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 06/20/2019; 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR