MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-8-30-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that when the coil was withdrawn from the aneurysm to adjust its position, it could not be pushed.The coil was stuck in the microcatheter.The reported devices and any accessory devices were prepared and the catheter was flushed as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the cavernous sinus segment with a max diameter of 7mm and a 5mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.The access vessel was the femoral artery.No patient symptoms or further complications were reported as a result of this event.Additional information received that the resistance was located in the middle of the catheter.The coil came out of the introducer sheath smoothly.There was no kink/damage to the coil observed after removal.
Additional Manufacturer Narrative
H3: product analysis of qc-8-30-3d, lotno:224973811 found the axium pusher fully pulled into the micro catheter ~8.7cm from the hub.The pusher was extending out the distal tip ~40.0cm.The coin was found still against the lumen stop, and the shield coil was undamaged.The shield coil was undamaged, and the implant coil and coil shell weld were separated from the detach element stick and not returned for analysis.After the pusher was cut out of the micro catheter, the pusher was found undamaged.Testing/analysis: the echelon-10 micro catheter total length was measured to be ~155.1cm and the usable length was measured to be ~1 47.4cm, which is within specification (specification: total (ref) = 155cm, usable: 147cm ± 1.5cm).The pusher was found stuck within the micro catheter and the catheter had to be cut to remove.The hub inner diameter could not be measured as it was damaged during the extraction of the pusher.The distal inner diameter was measured to be 0.0165¿, which is within specification (specification: 0.0165¿minimum).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ and ¿coil resistance stuck in catheter¿ could not be confirmed.The device was returned with the axium device already fully deployed.In addition, the device was further pulled distally into the echelon-10 micro catheter.The proximal axium pusher is not intended to fully pass through the catheter.There was no damages or irregularities found with the echelon-10 micro catheter that would contribute towards the resistance.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17343533
• Report Number: 9612164-2023-03255
• Device Sequence Number: 6903568
• Product Code: KRD
• UDI-Device Identifier: 00836462010437
• UDI-Public: 00836462010437
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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: Health Professional
• Device Expiration Date: 08/28/2025
• Device Model Number: QC-8-30-3D
• Device Catalogue Number: QC-8-30-3D
• Device Lot Number: 224973811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2022
• 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
• Patient Sex: Unknown