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

Model Number	45-780620
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	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record 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 been returned to the manufacturer for analysis.The investigation is currently underway.
Event or Problem Description
It was reported that during an attempt to advance the coil, the coil detached in the catheter.Both segments were removed in their entirety from the patient along with the catheter.There was no reported intervention or patient injury.The patient was reported to be stable.
Additional Manufacturer Narrative
The device was returned with the catheter, introducer, pusher, and the implant coil; the coil was noted to be detached from the pusher.The pusher was noted to be within specification, with no kinks or damage observed along its length.The strain relief tip was slightly damaged; however, did not display any burn marks.The tie-knot section of the implant coil was noted to be properly secured.The coil did not have any damage; however, was noted to be slightly misshappen and closely wound along its entirety.The pusher was dissected to expose the attachment tether monofilament, and noted that the monofilament suffered a straight cut, and had a rebound length was within specification.Based upon the investigation findings and available information, the reported complaint can be confirmed.The root cause cannot be determined; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

• 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: 7712664
• Report Number: 2032493-2018-00145
• Device Sequence Number: 11423886
• Product Code: KRD
• UDI-Device Identifier: 00810170018312
• UDI-Public: (01)00810170018312(11)180215(17)230131(10)1802155W3
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/25/2018

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: 01/31/2023
• Device Model Number: 45-780620
• Device Catalogue Number: 45-780620
• Device Lot Number: 1802155W3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1