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

Model Number	45-750812
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2017
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 following items were returned for evaluation: 5f non-terumo sos catheter, catheter introducer tool, delivery pusher, and implant.A portion of the implant was within the 5f catheter with approximately 14cm extending from distal tip.Approximately 5cm of the visible coil was stretched as it extends distally from catheter.There was minimal damage to the distal most portion of the implant that is unstretched.There were no obvious signs of kinks or bends in catheter.The proximal knot-tie portion on the implant is intact and attached to pusher.The implant is severed just distal to knot-tie with evidence of bending forces.The monofilament is intact, and the electrical resistance is within specification.Upon dissecting the catheter, the distal shaped section is non-reinforced.The stretched coil extends approximately 12cm within catheter.The proximal end within the catheter is stretched, prolapsed, and severed.Since the implant is still attached to the pusher, the failure mode is a fractured coil with evidence of tensile and bending forces at the fractured section.The catheter had a sos shaped tip that was soft and non-reinforced by coil or braid in the distal 5cm.Per ifu, the d35 cx must be delivered through a double braid reinforced catheter.
Event or Problem Description
It was reported that during the repositioning of the 2nd coil for an internal iliac embolization, the pusher broke and was no longer connected to the coil.Both segments of the coil were removed along with the microcatheter from the patient.There was no reported intervention or patient injury.The patient was 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: 7043183
• Report Number: 2032493-2017-00291
• Device Sequence Number: 10794772
• Product Code: KRD
• UDI-Device Identifier: 00812636021058
• UDI-Public: (01)00812636021058(11)160224(17)210224(10)16022411
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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: Physician
• Device Expiration Date: 02/24/2021
• Device Model Number: 45-750812
• Device Lot Number: 16022411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 70