MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; VASCULAR EMBOLIZATION DEVICE

Model Number	45-750812
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 yet been returned to the manufacturer for analysis.
Event or Problem Description
It was reported that during an embolization procedure for a varicocele, the coil implant was noticed to be missing from the delivery system when it was in the vessel.The delivery system was removed.A second coil was selected when it was observed that the vessel was bleeding.The second coil was apparently implanted, the procedure was stopped, and the patient has a remaining varicocele.It was reported that it was not known if the bleed had occurred due to the stated malfunction.The anatomy was stated to be "not easy." an additional procedure is being considered.
Additional Manufacturer Narrative
Based on the investigation findings and available information, the reported complaint is confirmed.The implant was found separated from the pusher and inside the dispenser hoop.As there were no burn marks on the heater coil, the implant was not detached prematurely via detachment cycle, and was likely separated due to excessive force.The cause of the excessive force could not be determined from the returned state of the device.The reported complaint describes the implant as missing from the pusher, which indicates that the implant must have been separated prior to the procedure.Since the implant was inside the dispenser hoop, it is probable that the separation occurred during removal of the device from the dispenser hoop.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11683272
• Report Number: 2032493-2021-00140
• Device Sequence Number: 3495125
• Product Code: KRD
• UDI-Device Identifier: 00812636021058
• UDI-Public: (01)00812636021058(11)190822(17)240731(10)1908225J2
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 45-750812
• Device Catalogue Number: 45-750812
• Device Lot Number: 1908225J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/18/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other