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

Model Number	45-652050
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was reported unavailable for evaluation.Based on the information provided, the root cause of this complaint cannot be determined.
Event or Problem Description
It was reported that the physician was performing a splenic aneurysm embolization.Physician had a 6 fr cook raabe guiding sheath in the splenic artery.He advanced a terumo glidecatheter (non-tapered angel) into the aneurysm.When advancing the 20 x 50 framer through the glidecatheter, it got stuck at the end of the catheter and would not advance.When pulling back on the pusher wire, the coil detached in the glidecatheter.The glidecatheter was removed with the coil inside.The coil was discarded and not implanted.The device will not be returned.There was no reported patient injury.

• Brand Name: AZUR DETACHABLE FRAMING COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6087903
• Report Number: 2032493-2016-00271
• Device Sequence Number: 364100
• Product Code: KRD
• UDI-Device Identifier: 00810170016097
• UDI-Public: (01)00810170016097(11)151110(17)201110(10)151110EC1
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K122543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2016

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: 11/10/2020
• Device Model Number: 45-652050
• Device Lot Number: 151110EC1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1