MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 PERIPHERAL V-TRAK SYSTEM; EMBOLIZATION COIL

Model Number	45-482030-L
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2018
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 prior to use, the embolization coil was advanced out from the tip of the introducer sheath and the coil was found to be detached.The device was not used in the patient.
Additional Manufacturer Narrative
The delivery pusher was returned within the introducer sheath, and the implant coil was detached from the pusher.The implant coil had no evidence of damage along its full length.There was no evidence of blood or hydrogel expansion on the implant.The monofilament knot-tie and adhesive were noted to be intact on the implant coil.There was no evidence of damage on the pusher or the introducer sheath.The pusher had discoloration under the inner pet segment, just proximal to the heater coil that looked like possible corrosion.Because the complaint report mentioned possible flushing of the device, the device may have corroded during the return to microvention from exposure to saline, although this could not be confirmed.Striations and a curled end were noted on the monofilament, which is indicative of a tensile failure on the pusher.The investigation findings and available information confirmed tensile overload of the implant coil retaining monofilament.Although it could not be determined when the device was subjected to excessive tensile forces, the investigation did not reveal any specific evidence to suggest the issue was manufacturing related.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7286695
• Report Number: 2032493-2018-00033
• Device Sequence Number: 11242174
• Product Code: HCG
• UDI-Device Identifier: 00810170018084
• UDI-Public: (01)00810170018084(11)170505(17)220430(10)170505525
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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: 04/30/2022
• Device Model Number: 45-482030-L
• Device Catalogue Number: 45-482030
• Device Lot Number: 170505525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1