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

Model Number	45-782040
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A search for non-conformance associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has not been returned to the manufacturer for evaluation.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 during a splenic artery embolization treatment, the coil got stuck inside the catheter and detached.The coil was removed in its entirety along with the catheter.The catheter was flushed after removal from the patient, and the coil came out.There was no reported patient injury or intervention.The patient was reported to be stable.
Additional Manufacturer Narrative
Additional information: (d10, h3) the device was received by the manufacturer and analyzed.The pusher, implant, and introducer were returned for analysis.The microcatheter and dispenser hoop were not returned.The implant was found to be in good condition and without damage.The introducer was found to be in good condition.The implant was found to have the monofilament tether still attached.The tether measured 5.5cm.The length of the tether aligns with the attachment location on the pusher.The proximal end of the pusher was found to be in good shape and without damage.Damage was noted at the distal end in the form of a twisted body.The body of the pusher appeared to be doubled over itself.Coils were also found to be compressed on the body of the pusher.Furthermore, the heater coil strain relief was found to be damaged.Based on the investigation findings and available information, the reported complaint is confirmed; the implant was returned detached from the pusher.The microcatheter was not returned, preventing complete analysis of the reported complaint.The root cause cannot be definitively determined at this time.Though it cannot be confirmed, the reported complaint is consistent with a coil/pusher that became stuck in a microcatheter and broke upon retraction.Based on the condition of the coils, it is surmised that the catheter became kinked, resulting in the stuck unit.

• 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: 8660369
• Report Number: 2032493-2019-00151
• Device Sequence Number: 11234926
• Product Code: KRD
• UDI-Device Identifier: 00810170018404
• UDI-Public: (01)00810170018404(11)181005(17)230930(10)1810055ZA
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 05/09/2019

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: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 45-782040
• Device Catalogue Number: 45-782040
• Device Lot Number: 1810055ZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/31/2019
• 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
• Patient Age: 69 YR