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

Model Number	45-780828
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
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 was returned to the manufacturer for analysis.The investigation is currently underway.The device was used during the same procedure as was reported in mfr report # 2032493-2018-00214.
Event or Problem Description
It was reported that during advancement of the coil in the microcatheter, the coil stretched from the pusher wire and then detached.Both segments of the coil were removed in their entirety along with the microcatheter.There was no reported patient injury or intervention.The patient is reported to be good.
Additional Manufacturer Narrative
The pusher was returned for analysis.Investigation of the device revealed 31" of lead wire separation on the green wire approximately 22" from the proximal portion, and 18.5" of lead wire separation on the yellow wire approximately 14" from the proximal portion.The green and the yellow wire tips displayed stripped regions for attachment on the heater coil section.The lead wires were noted to be separated, and devoid of lamination on the proximal section.The gold connector was noted to be bent at the hypotube gold connector junction.Based upon the investigation findings and available information, the reported complaint can be confirmed; however, the exact root cause cannot be determined.
Additional Manufacturer Narrative
The pusher was returned for analysis.Investigation of the device revealed 31" of lead wire separation on the green wire approximately 22" from the proximal portion, and 18.5" of lead wire separation on the yellow wire approximately 14" from the proximal portion.The green and the yellow wire tips displayed stripped regions for attachment on the heater coil section.The lead wires were noted to be separated, and devoid of lamination on the proximal section.The gold connector was noted to be bent at the hypotube gold connector junction.Based upon the investigation findings and available information, the reported complaint can be confirmed; however, the exact root cause cannot be determined.

• 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: 7940151
• Report Number: 2032493-2018-00213
• Device Sequence Number: 1343505
• Product Code: KRD
• UDI-Device Identifier: 00810170018336
• UDI-Public: (01)00810170018336(11)160922(17)210831(10)160922LC7
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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: Health Professional
• Device Expiration Date: 06/16/2020
• Device Model Number: 45-780828
• Device Catalogue Number: 45-780828
• Device Lot Number: 160922LC7
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1