MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 HYDROCOIL DETACHABLE 20MM X 30CM; EMBOLIZATION COIL

Model Number	45-452030
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
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.The device was not returned to the manufacturer for evaluation.The root cause cannot be determined.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 an embolization coil implant would not advance more than 2 cm out of the tip of a support catheter during treatment of an abdominal aneurysm.The coil was retracted back into the catheter and advanced again, but no more than 2cm of the coil would exit the catheter tip.While attempting to remove the coil, the coil detached in the catheter.The coil was removed in its entirety together with the catheter.There was no reported intervention or patient injury.

• Brand Name: AZUR 35 HYDROCOIL DETACHABLE 20MM X 30CM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9508098
• Report Number: 2032493-2019-00298
• Device Sequence Number: 19217823
• Product Code: KRD
• UDI-Device Identifier: 00810170015045
• UDI-Public: (01)00810170015045(11)190822(17)240731(10)1908225JG
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• 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
• Report Date (Section B): 11/21/2019

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: Other
• Device Expiration Date: 07/31/2024
• Device Model Number: 45-452030
• Device Catalogue Number: 45-452030
• Device Lot Number: 1908225JG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1