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

Model Number	45-780828-L
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2018
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 has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during an embolization treatment, resistance was encountered in the microcatheter.During removal, resistance was encountered again, and the coil detached in the microcatheter.Both segments of the coil were removed along with the microcatheter in their entirety.There was no reported intervention or patient injury.The patient is reported to have no issues.
Additional Manufacturer Narrative
The device was returned without the pusher for analysis.The monofilament knot tie was noted to be intact on the implant, with the monofilament extending approximately 5cm proximal.There was evidence of kinking along the entire portion of the implant.The edge of monofilament was noted to have a diagonal surface with rough edges, and tensile striations leading into a fractured point.Based on the investigation, evidence of a tensile break was noted on the monofilament; however, with absence of the pusher, could not confirm the type of detachment.The root cause is unknown; however, the damage to the device exhibited evidence that it was subjected to excessive tensile force that exceeded its maximum strength specification.

• 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: 7347353
• Report Number: 2032493-2018-00049
• Device Sequence Number: 11340801
• Product Code: KRD
• UDI-Device Identifier: 00810170018336
• UDI-Public: (01)00810170018336(11)170104(17)211231(10)170104LC4
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 45-780828-L
• Device Catalogue Number: 45-780828
• Device Lot Number: 170104LC4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 111