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

Model Number	45-451520
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	10/31/2017
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 the embolization coil got stuck in the microcatheter in less than one (1) minute, and unexpectedly detached in the microcatheter.The coil was then advanced and implanted in the intended area with the remaining coil pusher.There was no reported intervention or patient injury.The patient was reported to be good.
Additional Manufacturer Narrative
The device was returned with the delivery pusher and glide catheter; the implant coil was not returned, as it remains implanted in the patient.There was evidence of damage to delivery pusher; the distal outer sleeve glue joint failed.A kink was noted on the pusher approximately 70cm from distal tip.The catheter was noted to have indentations in multiple locations along shaft.The distal end of monofilament was noted to have tensile failure, with evidence of a necking, uneven surface located approximately 2cm proximal to distal end of delivery pusher.Based upon the investigation findings and available information, the complaint of a broken coil could be confirmed.The root cause could not be determined; however, the device exhibited evidence that it was subjected to forces that exceeded its strength specification of the monofilament.

• Brand Name: AZUR DETACHABLE 35 SYSTEMS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7077197
• Report Number: 2032493-2017-00313
• Device Sequence Number: 1275348
• Product Code: KRD
• UDI-Device Identifier: 00810170015014
• UDI-Public: (01)00810170015014(11)161104(17)211031(10)161104QC1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

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: 08/31/2021
• Device Model Number: 45-451520
• Device Catalogue Number: 45-451520
• Device Lot Number: 161104QC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1