MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 CX DETACHABLE 16MM X 32CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-751632
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
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 an embolization coil was difficult to advance into the coil pack during a carto procedure.During removal of the coil, the implant coil detached with 25% of the coil placed in the treatment site within the coil pack and 75% of the coil inside the catheter.The coil segment in the catheter was removed together with the catheter and the other coil segment remains implanted in the patient.There was no reported patient injury or additional intervention.The patient's current condition is reported as "stable.".
Event or Problem Description
It was reported that an embolization coil was difficult to advance into the coil pack during a carto procedure.After removal of the pusher from the patient, the coil was noted to be detached from the pusher wire.The catheter was removed together with the detached coil segment and replaced to complete the procedure.No portion of the coil remains in the patient.There was no reported patient injury or additional intervention.The patient's current condition is reported as "stable.".
Additional Manufacturer Narrative
Both segments of the coil were returned with the microcatheter.The pusher's proximal and distal sections were undamaged and met specifications.The microcatheter was kinked at the distal section.The implant coil was stuck inside of the microcatheter.The implant coil was stretched and detached.The monofilament had a tail shape.The implant coil's distal section was undamaged.The implant was returned stretched and stuck within the microcatheter and the microcatheter was also damaged.The damage to the microcatheter would have resulted in increased friction during advancement.Excessive retraction force following the coil becoming stuck likely resulted in the implant separating from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage to the microcatheter, but the damage is consistent with the device experiencing forces over specification.H11: b5: revised event / problem.

• Brand Name: AZUR 35 CX DETACHABLE 16MM X 32CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10366009
• Report Number: 2032493-2020-00193
• Device Sequence Number: 951035
• Product Code: KRD
• UDI-Device Identifier: 00812636021096
• UDI-Public: (01)00812636021096(11)191002(17)240930(10)1910025J2
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• 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): 07/07/2020

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: 09/30/2024
• Device Model Number: 45-751632
• Device Catalogue Number: 45-751632
• Device Lot Number: 1910025J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1