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

Model Number	45-780202
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	03/26/2019
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.The coil remains implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause cannot be determined.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during re-positioning of the coil in the intended treatment area, the coil detached without use of the v-grip controller.The coil remains implanted in the patient.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
Corrected data (h10): original report stated ".The remainder of the device was discarded at the user facility." the device was received for evaluation.Additional information (d10, h3): the device was received for analysis.The customer supplied fluoroscopic images, but they are of such limited quality that no specific conclusions can be drawn in their relationship to the complaint of the coil detaching while not connected to the detachment controller.The delivery pusher and introducer were returned for analysis.The microcatheter, implant, and dispenser hoop were not returned.The pusher was extended approximately three inches outside the tip of the introducer upon return.The introducer was removed and inspected, and no damage was observed.The proximal end of the pusher was found to be in good condition and without damage.The heater coil was not found to show signs of in-air thermal detachment.Just proximal to the heater coil region, two damaged areas were noted on the pusher.The pusher was found to be twisted and buckled over itself.The monofilament was removed from the pusher for analysis.The monofilament was found to be smashed and torn.The root cause cannot be definitively identified, but the damage to the pusher body is historically related to excessive forces experienced by the pusher.It appears that it sustained compression and torsion forces it is suspected that the pusher was either pinched or caught in the microcatheter and pulled and manipulated on retraction.The microcatheter was not returned, preventing further analysis.

• 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: 8567530
• Report Number: 2032493-2019-00112
• Device Sequence Number: 19397448
• Product Code: KRD
• UDI-Device Identifier: 00816777024367
• UDI-Public: (01)00816777024367(11)170814(17)220731(10)170814538
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 07/31/2022
• Device Model Number: 45-780202
• Device Lot Number: 170814538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1