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

Model Number	45-780828-L
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2018
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 has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that while re-positioning an embolization coil in a splenic aneurysm, the coil detached partially in the microcatheter and partially in the aneurysm.The coil was pushed into the intended area with a pusher wire.There was no reported intervention or patient injury.The patient was reported to be fine.
Additional Manufacturer Narrative
The pusher was returned without the implant for analysis.There is minimal evidence of damage to the delivery pusher; however, there was a prolapsed section just distal to the monofilament knot-tie.The knot-tie was noted to be intact.The distal end of the monofilament was located approximately 1cm from distal tip of pusher.Tensile failure was noted, as evidenced with an uneven surface and necking.Based on the investigation, the monofilament portion of the pusher showed evidence of a tensile failure.The root cause is unknown; however, the damage to the device exhibited evidence that it was subjected to excessive tensile force that exceeded the maximum strength specification of the monofilament.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7250288
• Report Number: 2032493-2018-00023
• Device Sequence Number: 949569
• Product Code: KRD
• UDI-Device Identifier: 00810170018336
• UDI-Public: (01)00810170018336(11)161115(17)211031(10)161115LC8
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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: Physician
• Device Expiration Date: 10/31/2021
• Device Model Number: 45-780828-L
• Device Catalogue Number: 45-780828
• Device Lot Number: 161115LC8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 86