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

Model Number	QC-5-15-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is reported at this time based on analysis findings which indicated a possibly reportable device malfunction.H3.Product analysis: equipment used: video inspection system (m-85519), ruler (m-83361), pin gauge sets (m-84083, m-84081), camera (panasonic lumix dmc-zs5), 0.0165¿ mandrel as found condition: the echelon-10 micro catheter and axium coil were returned for analysis within a shipping box and within a sealed plastic biohazard pouch.Echelon-10 returned further within a plastic glove.Axium coil returned further within a dispenser coil and within an introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the axium pusher.The axium implant coil was found stretched and damaged within the introducer sheath with the polypropylene filament broken.No flash or hub mold were found within the echelon-10 hub.No damages or irregularities were found with the echelon-10 micro catheter hub.The distal micro catheter exhibited evidence of steam shaping.The tip and marker band were found crushed.Testing/analysis: the returned coil could not be advanced out of the introducer sheath as it was found to be stuck and cannot be used for resistance testing due to the damages.The echelon-10 total length was measured to be ~152.8cm and the useable length was measured to be ~145.8cm which is within specification (specification: total (ref) = 152cm, usable: 144cm ±1.5cm).The echelon-10 micro catheter was flushed, and water exited out the distal end.An in-house 0.0165¿ mandrel was inserted into the echelon-10 micro catheter hub, through the catheter body and out the distal end with resistance encountered at the damaged tip/marker band.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 at the reported proximal end; however, resistance was encountered during in-house mandrel resistance testing at the damaged distal end.Possible causes for the damaged distal tip/marker band are patient vessel tortuosity, catheter entrapment, user advances/retrieves the coil against resistance, or due to catheter tip shaping.The axium implant coil was found stretched/damaged, potentially due to advancing against the reported resistance.The axium coil is compatible for use with the echelon-10 micro catheter.There is no indication that the event is related to a potential manufacturing issue.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the axium coil encountered resistance in the echelon catheter.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm in the left posterior communicating artery with a max diameter of 13 mm and a 7 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that the facility treated a case of intracranial aneurysm.After the angiographic diagnosis, 6 gaiding + echelon mic rocatheter + johnson & johnson 21 microcatheter were used to establish access.  after the stent catheter and stuffing catheter were in place, delivered into the lvis stent and semi-deployment, and qc3d coil 18-40 was selected to place into the tumor and form hoop.After angiography, two qc3d coils 14-40, one qc3d coil 12-40, two qc3d coils 7-30, and two prime3d coils 6-20 were selected and placed into the tumor.After angiography, selected 5-15 qc3d coil.During the process of entering the echelon-10 microcatheter, the spring coil was difficult to delivered into it and it could not be pushed.After the radiography tumor was not developed, the stent was developed and the surgery was over.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Additional information received that the cause of the resistance was not determined.The resistance was located in the proximal section of the catheter.The coil came out of the introducer sheath smoothly.The continuous flush was delivered during the procedure.There was a slight kink observed to the coil after removal.

• 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: 19588409
• Report Number: 9612164-2024-02944
• Device Sequence Number: 3506087
• Product Code: KRD
• UDI-Device Identifier: 00847536037816
• UDI-Public: 00847536037816
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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: 08/10/2026
• Device Model Number: QC-5-15-3D
• Device Catalogue Number: QC-5-15-3D
• Device Lot Number: 227135714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 50 KG