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

Model Number	45-780413-L
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has been returned to the manufacturer.The investigation is underway.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during advancement within a catheter, an embolization implant coil detached.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The pusher was received for evaluation.The microcatheter, implant, and introducer were not returned.The pusher did not display any notable damage.The heater coil of the pusher did not display any burn marks.The attachment monofilament was dissected out of the pusher and the monofilament tip was observed to have a stretched tail.Based on the investigation, the complaint is confirmed because the pusher was found without the implant.The implant most likely did not detach by normal methods and most likely experienced a pull force over specification that caused it to detach.The cause of the force could not be determined as the microcatheter and implant were not returned for evaluation.

• 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: 8947762
• Report Number: 2032493-2019-00202
• Device Sequence Number: 14222904
• Product Code: KRD
• UDI-Device Identifier: 00810170018299
• UDI-Public: (01)00810170018299(11)180316(17)230228(10)1803165W3
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 02/28/2023
• Device Model Number: 45-780413-L
• Device Catalogue Number: 45-780413
• Device Lot Number: 1803165W3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1