MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACHABLE HYDRO; EMBOLIZATION COIL

Model Number	45-480305-L
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the approved device history records indicated the lot met all release criteria.The coil was returned for evaluation.The delivery pusher and introducer sheath were not returned for evaluation.Visual inspection revealed the coil was not attached to the delivery pusher, and the proximal end of the coil was stretched.The hydrocoil's maximum time of exposure to fluid is 5 minutes before the gel starts to react.Beyond this timeframe, the coil will expand to its maximum od.The condition of the returned sample is consistent with the device being over-exposed to fluid beyond its timeframe.Based on the available information and the evaluation of the device, the reported coil break can be confirmed as the coil is not attached to the delivery pusher.The root cause of this complaint cannot be determined; however, the condition of the returned device is consistent with device being over-exposed to fluid beyond its timeframe, and the expansion of the implant may have caused the difficult withdrawal through the microcatheter, resulting in excessive retraction force being placed on the device which may have led to the implant coil separating from pusher.
Event or Problem Description
It was reported that treatment was being performed in the gastric artery.The hydrogel coil was extended out of the microcatheter to soften it; however, while bringing it back into the microcatheter, the coil detached half in and half out of the microcatheter.During withdrawal of the microcatheter and coil from the patient, the coil became stuck in the 5 fr.Femoral introducer sheath.The sheath, microcatheter, and coil in its entirety were removed together as a single unit from the patient.Femoral access was then gained in the left femoral artery to perform the procedure.The patient is reported to be stable and there was no reported patient injury.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6022890
• Report Number: 2032493-2016-00244
• Device Sequence Number: 18968983
• Product Code: KRD
• UDI-Device Identifier: 00810170017872
• UDI-Public: (01)00810170017872(11)160309(17)210309(10)160309LC3
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2016

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: Physician
• Device Expiration Date: 03/09/2021
• Device Model Number: 45-480305-L
• Device Lot Number: 160309LC3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 10/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1