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

Model Number	RFX072-115-08MP
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navien catheter that was damaged.The patient was undergoing an emergency thrombectomy procedure via femoral access to treat a large vessel occlusion.Patient vessel tortuosity was minimal.It was reported that after opening, it was observed that the distal navien catheter tip was crushed.The damaged catheter was replaced with a new one.There was no harm or injury to the patient associated with this event.Additional information received that there was no damage or evidence of tampering to device packaging.The damage was not noticed upon opening the package.Routine surgical procedures were performed before it was observed.The device was used at all in the patient's body.
Additional Manufacturer Narrative
Product analysis: as found condition: the navien catheter was returned for analysis within a shipping box, a plastic bio-pouch, and an opened navien inner pouch (b690164).Damage location details: no damages were found with the navien catheter hub.No bends or kinks were found with the navien catheter body.The navien catheter distal marker/tip was found separated from the catheter.The separated catheter distal tip was not returned.The tubing material at the separated end exhibited plastic deformation (jagged edges) with the braid exposed, indicating that the catheter likely separated when exceeding the tensile strength of the tubing material.Testing/analysis: none conclusion: based on the device analysis and reported information, the customer¿s report was confirmed.During the analysis, the navien catheter distal marker/tip was found separated, likely due to tensile failure.This can occur if the device is retrieved against resistance, damaged during preparation, vessel tortuosity, or hard clots/calcifications in the navigation tract, which may snag the catheter.However, the cause of the catheter separation could not be determined.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: 21763064
• Report Number: 2029214-2025-00872
• Device Sequence Number: 8811758
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: 02/07/2026
• Device Model Number: RFX072-115-08MP
• Device Catalogue Number: RFX072-115-08MP
• Device Lot Number: B690164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/03/2025
• Date Device Manufactured: 02/08/2024
• 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
• Patient Age: 86 YR
• Patient Sex: Male