MAUDE Adverse Event Report: MICROVENTION, INC AZUR 35 CX DETACHABLE 16MM X 32CM; EMBOLIZATION COIL

Model Number	45-751632
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	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.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 returned to the manufacturer.The investigation is currently underway.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 became detached inside of a cordis brand catheter.The embolization coil was removed in its entirety along with the catheter.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
Only the implant coil was returned.The coil was found to be broken and stretched.The monofilament was stretched and broken and was inside of the implant coil.The pusher was not returned, so the investigation could not perform further analysis.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.No other components were returned as part of this investigation, so it cannot be determined what contributing factors led to the reported event.

• Brand Name: AZUR 35 CX DETACHABLE 16MM X 32CM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9389499
• Report Number: 2032493-2019-00279
• Device Sequence Number: 1814424
• Product Code: KRD
• UDI-Device Identifier: 00812636021096
• UDI-Public: (01)00812636021096(11)190625(17)240531(10)1906255J2
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 05/31/2024
• Device Model Number: 45-751632
• Device Catalogue Number: 45-751632
• Device Lot Number: 1906255J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/28/2019
• Supplement 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