MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 PERIPHERAL V-TRAK SYSTEM; EMBOLIZATION COIL

Model Number	45-480410-L
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the 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 will not be returned for evaluation; therefore, a product analysis will not be performed.The root cause cannot be determined.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report or the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that after attempting to position an embolization coil in the arteriovenous malformation, the physician passed a wire down the left anterior descending artery.Resistance was encountered when attempting to advance the coil in the microcatheter.The pusher broke 1cm proximal to the coil attachment point.The detached coil was successfully retrieved with a snare device.There was no reported patient injury.The patient was reported to be stable.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7311572
• Report Number: 2032493-2018-00043
• Device Sequence Number: 19071807
• Product Code: KRD
• UDI-Device Identifier: 00810170017902
• UDI-Public: (01)00810170017902(11)170127(17)211231(10)170127LC1
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K091882
• 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
• Report Date (Section B): 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 45-480410-L
• Device Catalogue Number: 45-480410
• Device Lot Number: 170127LC1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 109