MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACH PLATINUM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	45-682050-L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 not yet been returned to the manufacturer for evaluation.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 a peripheral coil embolization procedure, the embolization coil detached in the microcatheter.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The investigation of the returned implant found the monofilament to contain a stretched tail profile, which is consistent with the implant separating from the pusher due to excessive tensile force rather than a thermal detachment using a detachment controller.The delivery pusher was not returned for evaluation.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.

• Brand Name: AZUR-18 DETACH PLATINUM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10953717
• Report Number: 2032493-2020-00362
• Device Sequence Number: 11592504
• Product Code: HCG
• UDI-Device Identifier: 00810170017834
• UDI-Public: (01)00810170017834(11)200228(17)250131(10)2002285K5
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 45-682050-L
• Device Catalogue Number: 45-682050
• Device Lot Number: 2002285K5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1