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

Model Number	45-780304-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	12/14/2017
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.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 underway.
Event or Problem Description
It was reported that several coils had been placed in an active gastrointestinal bleed.During positioning of the final coil, resistance was encountered and the coil was withdrawn.During removal, the coil felt "sticky," and half of the coil detached in the microcatheter with the other half in the intended treatment area.Both segments of the coil were removed in their entirety together with the microcatheter and the guiding catheter as a single unit.There was no reported patient injury.The patient was reported to be stable.
Additional Manufacturer Narrative
An embolization coil was returned for inspection; however, the visual inspection of the coil revealed that the coil was helical in shape with fibers extending from the primary wind, which confirms the returned device is not the device associated with the reported complaint.As the actual complaint device was not returned for evaluation, the reported complaint could not be confirmed.The root cause could not be determined.

• 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: 7204357
• Report Number: 2032493-2018-00011
• Device Sequence Number: 143214
• Product Code: KRD
• UDI-Device Identifier: 00816777024381
• UDI-Public: (01)00816777024381(11)170719(17)220630(10)1707191L4
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/19/2017

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: 06/30/2022
• Device Model Number: 45-780304-L
• Device Lot Number: 1707191L4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 76