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

Model Number	45-681434
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
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 has been returned to the manufacturer; 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 while advancing the coil out of the microcatheter, which was in position, the coil only advanced a few inches and then detached at its detachment point.The coil was advanced into the target site with the glidewire.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
Only the pusher and introducer were returned for analysis.The microcatheter, implant, and dispenser hoop were not returned.A review of the pusher found the proximal end to be in good condition and without damage.The distal end of the pusher was found to have a minor fold in the strain relief.Just distal of the attachment location, the pusher was found to be twisted and bent.No damage was identified on the introducer.The monofilament was removed from the pusher for further analysis.The distal end of the monofilament was found to have an elongated tail profile; this profile is characteristic of a unit that has been subjected to tensile forces.Based on the investigation findings and available information, the reported complaint is confirmed.Only the pusher was returned, preventing detailed analysis of the reported incident.The root cause cannot be definitively determined at this time, though the damage profile on the monofilament displayed that of a tensile force break.Additionally, the damage sustained to the pusher displays signs of being advanced under excessive force.The microcatheter is considered a critical component to fully investigate the reported complaint.

• Brand Name: AZUR DETACHABLE FRAMING COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8756056
• Report Number: 2032493-2019-00168
• Device Sequence Number: 19249722
• Product Code: HCG
• UDI-Device Identifier: 00810170017803
• UDI-Public: (01)00810170017803(11)180903(17)230831(10)180903529
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: 08/31/2023
• Device Model Number: 45-681434
• Device Catalogue Number: 45-681434
• Device Lot Number: 180903529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR