MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 CX DETACHABLE 4MM X 13CM; VASCULAR EMBOLIZATION DEVICE

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	06/24/2020
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 was returned to the manufacturer for evaluation.The investigation is currently underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during advancement of an embolization coil, a lot of resistance was encountered and the coil detached in the microcatheter.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The coil implant was the only component received for evaluation.Inspection of the implant revealed a bend at the marker band and proximal glue bond section.This bend would have resulted in an oversized effective diameter, which could have caused increased friction during advancement or retraction.Based on the investigation findings, the separation of the implant is consistent with the implant becoming stuck and then experiencing retraction forces that exceeded the strength of the monofilament.

• Brand Name: AZUR 18 CX DETACHABLE 4MM X 13CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10439875
• Report Number: 2032493-2020-00226
• Device Sequence Number: 19574065
• Product Code: KRD
• UDI-Device Identifier: 00810170018299
• UDI-Public: (01)00810170018299(11)191105(17)241031(10)1911055ZA
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: 10/31/2024
• Device Model Number: 45-780413-L
• Device Catalogue Number: 45-780413
• Device Lot Number: 1911055ZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1