MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; PERIPHERAL

Model Number	45-780928-L
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
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 was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.The instructions for use (ifu) identifies coil non-detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during embolization of a pediatric varicocele, two coils were successfully deployed at the treatment site.Another coil was going to be deployed to complete the coil packing however, the coil did not detach with multiple attempts including torquing.The coil could not be pulled out using various base catheters.Converted to laparoscopic to cut varicocele.The coil was able to be pulled from the groin, but it had stretched out the length of the varicocele.The coil was removed via scope.Fluro exam was performed to verify no pieces had broken off in the patient.The coil pack had pulled back into renal vein/ivc.A snare was introduced to remove the coil pack out of the patient.The patient is reported to be stable.The treatment was ultimately successful taking another direction for treatment.
Additional Manufacturer Narrative
Items returned for evaluation: pusher, microcatheter.Items not returned for evaluation: implant, introducer, dispenser hoop, shrink lock, v-grip.The visual analysis of the returned items found the implant not attached to the pusher with the heater coil burnt, the pusher twisted at the distal section, and the lead wires broken and separated from the core wire at the middle section of the pusher.The implant was not returned for evaluation.Investigation of the pusher found the monofilament with a mushroom profile, which indicates the implant was successfully detached from thermal activation.The returned microcatheter was found to be in good condition with no observable damage.Replication testing of the advancement/retraction of the device through the returned microcatheter was unable to be performed due to the condition of the returned device.Furthermore, the device could not be tested to determine if a condition existed that would have caused or contributed to an intermittent connection between the detachment controller and coil system (delayed detachment) due to the broken lead wires.The v-grip controller used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported detachment issue.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: PERIPHERAL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terry callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16519171
• Report Number: 2032493-2023-00607
• Device Sequence Number: 15017547
• Product Code: KRD
• UDI-Device Identifier: 00810170018343
• UDI-Public: (01)00810170018343(11)210115(17)251231(10)2101155Z8
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K1123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 45-780928-L
• Device Catalogue Number: 45-780928
• Device Lot Number: 2101155Z8
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male