MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number	RFX072-115-08MP
Medical Device Problem Codes	Difficult to Advance (2920); Unintended Movement (3026); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient had an aneurysm in the horizontal segment of the middle cerebral artery, and the surgeon planned to treat it with a dense mesh stent pipeline + coil.The surgery began with establishing an access, pushing a 6fnavien, and planning to insert a marksman and echelon in parallel with the navien.In actual operation, after the 6fnavien reached the ophthalmic artery, it could not be pushed up any further and stabilized at the horizontal segment of the cavernous sinus.So the surgeon changed their strategy and delivered the marksman, encountering resistance in the distal section during the delivery process.After finally raising the marksman up to m2, when delivering the echelon, the marksman tip was unstable and fell off again.The surgeon repeated operations twice and found that the marksman and echelon were unstable in the navien.In order to prevent accidents when deploying the pipeline later, the surgeon replaced it with a new microcatheter phenom27 and 5fnavien, re-punctured on the left side, punctured both sides, deployed the pipeline on one side, and filled the coil on the other side to treat the aneurysm.The reported devices and any accessory devices were prepared and the catheters were flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of an aneurysm of the internal carotid middle cerebral artery.It was noted the patient's vessel tortuosity was moderate.The access vessel was the femoral artery with a 8mm diameter.Ancillary devices include a 8f puncture sheath, 8f guiding catheter, echelon 10, marksman, and phenom 27 microcatheters, sychro guidewire, and qc-4-8-3d, apb-3.5-10-3d, apb-2-6-3d coils.Additional information was received that there was catheter kick back.The cause of the resistance may have been due to vascular tortuosity and excessive system tension.
Additional Manufacturer Narrative
Continuation of d10: product id fa-55150-1030 (lot: 227258509); product type: ; implant date n/a; explant date n/aproduct id unk-nv-echelon (lot: unknown); product type: ; implant date n/a; explant date n/a 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.
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the marksman and navien catheters were returned for analysis within a shipping box, a plastic pouch, and opened inner pouches.¿ damage location details: no damages were found with the marksman catheter hub.The marksman catheter body was found kinked at ~17.0cm from the proximal end of the catheter hub.The marksman catheter distal tip was found to be in good condition.No damages were found with the navien catheter hub.The navien catheter body was found damaged at ~1.0cm from the catheter distal tip.The navien catheter distal marker/tip was found crushed.¿ testing/analysis: the marksman catheter surface was hydrated and the navien catheter flushed.The marksman catheter was then inserted into the navien catheter.However, the marksman catheter could not exit the distal tip of the navien catheter.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.

• Brand Name: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21375921
• Report Number: 2029214-2025-00414
• Device Sequence Number: 8431788
• Product Code: DQY
• UDI-Device Identifier: 00847536017924
• UDI-Public: 00847536017924
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110055
• 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,Followup
• Report Date (Section B): 04/28/2025

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: 01/18/2026
• Device Model Number: RFX072-115-08MP
• Device Catalogue Number: RFX072-115-08MP
• Device Lot Number: B682036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 60 KG