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

Model Number	45-750609
Medical Device Problem Codes	Detachment Of Device Component (1104); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
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.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that an embolization coil unexpectedly detached in the microcatheter without use of the controller.The coil was stretched; the physician was unable to push the coil out of the microcatheter with a guidewire or saline flush.Both segments of the coil were withdrawn together with the microcatheter, and removed in their entirety.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
The implant coil was returned for evaluation.The pusher wire was not returned.The majority of the coil was noted to be stretched, extending approximately 65cm, which suggests a tensile overload.The distal loops, 1.5-2 loops of the coil, were free of damage.The monofilament knot-tie was noted to be intact on the implant.Based on the returned device evaluation and the reported event details, the exact root cause cannot be determined; however, evidence of stretched coil damage to the implant indicates tensile forces were applied, which indicates the tensile strength of the monofilament was exceeded.

• 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: 6950001
• Report Number: 2032493-2017-00261
• Device Sequence Number: 13623955
• Product Code: KRD
• UDI-Device Identifier: 00812636021034
• UDI-Public: (01)00812636021034(11)160610(17)210610(10)16061011
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/15/2017

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: Physician
• Device Expiration Date: 06/10/2021
• Device Model Number: 45-750609
• Device Lot Number: 16061011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1