MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; EMBOLIZATION COIL

Model Number	45-750609
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record 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 has been returned to the manufacturer for evaluation.The investigatioin is currently underway.The device was used during the same procedure as was reported in mfr report# 2032493-2017-00109.
Event or Problem Description
It was reported that during treatment of a left groin a-v fistula, the embolization coil broke off in a bern catheter and appeared to separate.There was no reported intervention or patient injury.The current patient's status is reported to be "fine.".
Additional Manufacturer Narrative
The device was returned for evaluation.Analysis revealed evidence the coil was stretched starting approximately 2.5cm from distal end of coil, and continuing to the knot-tie at the proximal end.The knot and monofilament were noted to be intact and connected to pusher.The strain relief was slightly folded on one side.There was no evidence of damage to the pusher.Based on the investigation and provided information, the complaint of a detached implant cannot be confirmed.The implant coil was attached to the pusher and not broken; however, the coil was noted to be stretched.The specific root cause of this complaint cannot be determined.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6525753
• Report Number: 2032493-2017-00108
• Device Sequence Number: 19168697
• Product Code: KRD
• UDI-Device Identifier: 00812636021034
• UDI-Public: (01)00812636021034(11)160610(17)210610(10)16061011
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K122316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2017

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: 06/10/2021
• Device Model Number: 45-750609
• Device Lot Number: 16061011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 128