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

Model Number	45-782040
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult To Position (1467)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
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 to the manufacturer.The investigation is currently underway.
Event or Problem Description
It was reported that multiple attempts were made to position the coil.1/2 of the coil was positioned; however, the coil was unable to advance further and detached in the catheter.Both segments of the coil were removed in their entirety along with the catheter.There was no reported intervention or patient injury.The patient was reported to be stable.
Additional Manufacturer Narrative
The coil was returned for analysis; the pusher was not returned.The implant was noted to be in good shape, with the tie-knot properly secured.The entire implant coil was closely wound.The stretch resistant member within the coil was noted to be broken.The implant appeared to be within specification.Based on the reported details and investigation findings, the complaint could be confirmed.The exact 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: 7599254
• Report Number: 2032493-2018-00112
• Device Sequence Number: 19238437
• Product Code: KRD
• UDI-Device Identifier: 00810170018404
• UDI-Public: (01)00810170018404(11)180206(17)230131(10)1802065W3
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/15/2018

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: 01/31/2023
• Device Model Number: 45-782040
• Device Catalogue Number: 45-782040
• Device Lot Number: 1802065W3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR