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

Model Number	45-781032
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	09/04/2018
Type of Reportable Event	Malfunction
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 was returned to the manufacturer for analysis.The investigation is currently underway.The device was used during the same procedure as was reported in mfr report# 2032493-2018-00213.
Event or Problem Description
It was reported that during advancement of the coil, the coil detached in the microcatheter.Both segments were removed in their entirety along with the microcatheter.There was no reported patient injury or intervention.The patient is reported to be good.
Additional Manufacturer Narrative
The coil was returned with pusher for analysis.The implant was noted to be stretched on the proximal section, a few coil revolutions after the tie-knot.The middle portion of the implant had retained it secondary shape.There was no evidence of burn marks observed on the pusher heater coil section.The attachment tether monofilament appeared wavy inside the pusher body coils.The attachment tie-knot section was noted to be in conformance; however, it was dissected to expose the attachment tether tip and identify the type of detachment.Further analysis revealed that the attachment tether tip had a flat cut, and a rebound length of 0.280".Based upon the investigation findings and available information, the reported complaint can be confirmed.The root cause cannot be determined; however, the device exhibited 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: 7940159
• Report Number: 2032493-2018-00214
• Device Sequence Number: 11266301
• Product Code: KRD
• UDI-Device Identifier: 00810170018350
• UDI-Public: (01)00810170018350(11)160921(17)210831(10)160921LC6
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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: 08/31/2021
• Device Model Number: 45-781032
• Device Catalogue Number: 45-781032
• Device Lot Number: 160921LC6
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1