MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 CX DETACHABLE 6MM X 20CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-780620
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
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 discarded by the physician and was not returned for evaluation.The root cause cannot be determined.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that an embolization coil detached within the microcatheter without use of the controller.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The introducer, pusher and implant were returned for analysis.Investigation into the returned components found the strain relief of the pusher to be folded in.The pusher's lead wires were separated from the core wire of the pusher toward the proximal end.During further inspection, the implant was found to have overlapping coils at multiple locations and also was found stretched toward the proximal end of the implant.The monofilament's tip profile displayed a tail, suggesting a tensile break.Lead wire separation was found along the length of the pusher.Lead wire separation is consistent with the device experiencing friction during advancement.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.Inspection of the pusher's monofilament found at stretched tail, which is indicative of the implant separating due to tensile forces that exceeded the strength of the monofilament.The origin of the force placed on the device could not be determined.

• Brand Name: AZUR 18 CX DETACHABLE 6MM X 20CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9730236
• Report Number: 2032493-2020-00038
• Device Sequence Number: 353393
• Product Code: KRD
• UDI-Device Identifier: 00810170018312
• UDI-Public: (01)00810170018312(11)191107(17)241031(10)1911075ZA
• Combination Product (Y/N): N
• 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): 01/20/2020

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: 45-780620
• Device Catalogue Number: 45-780620
• Device Lot Number: 1911075ZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1