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

Model Number	45-750609
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	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances 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 been returned to the manufacturer.The investigation is underway.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 embolization of a fistula collateral, the embolization coil would not advance out of the catheter tip or retract.It was determined that the coil detached.The coil could not be advanced with a pusher, and so the entire catheter was removed with the implant coil.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The pusher, introducer, and dispenser hoop were not returned for analysis.Review of the unit found the distal end of the implant to be protruding from the catheter.The implant was stretched where it exited distally from the catheter.The distal loops were intact.Attempts to flush the catheter to free the implant were unsuccessful.The catheter was excised to determine the mechanics of the failure to advance.The implant was found to be stretched through to the proximal end.The proximal end of the implant was found to be "train wrecked." this location prevented the advancement/retraction of the implant.No damage was noted on the catheter.Based on the investigation findings and available information, the reported complaint is confirmed.The implant was found to be stuck in the catheter upon receipt.The pusher was no longer attached to the implant.The investigation determined that the implant experienced train-wrecking.The investigation could not confirm the circumstances that led to the damage to the implant, but the damages are consistent with the implant becoming stuck during advancement and experiencing compression forces (i.E.Advancement forces) over specification which caused the train-wrecking; tensile forces (i.E.Retraction forces) that exceeded the strength of the coil and the attachment monofilament likely caused the stretching and separation from the pusher.

• 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: 8923747
• Report Number: 2032493-2019-00199
• Device Sequence Number: 13960216
• Product Code: KRD
• UDI-Device Identifier: 00812636021034
• UDI-Public: (01)00812636021034(11)161208(17)211130(10)16120811
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• 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): 07/24/2019

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: 11/30/2021
• Device Model Number: 45-750609
• Device Catalogue Number: 45-750609
• Device Lot Number: 16120811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 86