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

Model Number	45-652050
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	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was returned with the pusher and 4fr glide catheter for analysis.The strain relief on the distal heater coil section was noted to be slightly folded.The heater coil appeared compressed.The implant coil was noted to be stuck inside the catheter and was unable to be removed despite repeated flushing.The proximal section of the pusher was extremely stretched.The pusher was dissected to expose the attachment tether tip shape.The attachment tether tip was twisted and appeared to have detached from repetitive manipulations.Based on the available information and evaluation of the returned device, the complaint can be confirmed.The root cause cannot be determined; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during advancement through a 4f catheter, the embolization coil became stuck.During the attempt to remove the coil, it detached in the catheter.Both segments of the coil were removed from the patient together with the catheter.There was no reported patient injury or intervention.

• 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: 7926392
• Report Number: 2032493-2018-00209
• Device Sequence Number: 1936931
• Product Code: KRD
• UDI-Device Identifier: 00810170016158
• UDI-Public: (01)00810170016158(11)180518(17)230430(10)18051855B
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111307
• 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
• Report Date (Section B): 09/04/2018

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: 04/30/2023
• Device Model Number: 45-652050
• Device Catalogue Number: 45-652050
• Device Lot Number: 18051855B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 72