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

Model Number	45-780413
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
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 for evaluation; the implant was not attached to the pusher.The pusher was noted to have kinks in the middle portion of the lead wire.There was also lead wire separation approximately 22" from the proximal gold connector section.The was no damage, kinks, or stretching noted on the coil; however, there was slight shape deformity.The tie-knot section of the coil was noted to be intact and within specification.The pusher was dissected to expose the attachment tether monofilament.The monofilament was noted to have a stretched tail, and the rebound length was low, per specification.Based on the available information and evaluation of the returned device, the complaint can be confirmed, the root cause cannot be determined; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that resistance was encountered during advancement of the coil in the microcatheter, and the coil detached.Both segments were removed in their entirety along with the microcatheter.There was no reported intervention or patient injury.The patient is reported to be stable.

• 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: 7737707
• Report Number: 2032493-2018-00151
• Device Sequence Number: 2643934
• Product Code: KRD
• UDI-Device Identifier: 00810170018299
• UDI-Public: (01)00810170018299(11)170316(17)220228(10)170316LC2
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 02/28/2022
• Device Model Number: 45-780413
• Device Catalogue Number: 45-780413
• Device Lot Number: 170316LC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1