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

Model Number	45-782040
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	08/13/2019
Type of Reportable Event	Serious Injury
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 embolization of a splenic artery aneurism, the implant coil became stuck in the microcatheter.Stronger force was placed in the device in order to advance it, but it would not advance.During attempts to withdraw the device and microcatheter together, the implant coil became detached.A snare was used to retrieve the implant coil.The patient did not experience any reported sequelae.
Additional Manufacturer Narrative
The pusher and implant were received for evaluation.The microcatheter and introducer were not returned.The implant was found detached from the pusher, damaged, and was stretched.The proximal portion of the implant did not present any notable abnormalities.The heater coil of the pusher did not have any signs of burn damage.The body coil of the pusher was bent and wavy.The core wire was kinked and lead wire separation was observed at that location.The attachment monofilament in the pusher was dissected and the monofilament tip was found to have a stretched tail shape.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage to the pusher is consistent with the device experiencing advancement forces over specification, and the implant was determined to have separated from the pusher due to excessive tensile forces.The investigation determined that it is likely that the device experienced advancement difficulties as described in the complaint.Lead wire separation and advancement issues are tracked by quality and manufacturing for this product.

• 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: 9050528
• Report Number: 2032493-2019-00224
• Device Sequence Number: 14173670
• Product Code: KRD
• UDI-Device Identifier: 00810170018404
• UDI-Public: (01)00810170018404(11)190405(17)240331(10)1904055ZA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 03/31/2024
• Device Model Number: 45-782040
• Device Catalogue Number: 45-782040
• Device Lot Number: 1904055ZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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