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

Model Number	RFX072-115-08MP
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Ruptured Aneurysm (4436); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 patient had multiple intracranial aneurysms of the right internal carotid artery, including a large 10mm aneurysm at the posterior communicating artery segment and a small 4mm aneurysm at the ophthalmic artery segment.The operator planned to implant a pipeline for treatment.During the procedure to establish access, it was found that the microcatheter could not enter the lumen of the navien due to significant resistance.After replacing with a new one, it went through successfully.The marksman microcatheter was positioned, and a ped-450-30 was delivered to the distal end of the microcatheter.However, the stent could not be came out despite being able to be retrieved.Multiple attempts were made with increased pushing force, but the problem persisted.Subsequently, possibly due to repeated forceful manipulation, the aneurysm suddenly ruptured during the procedure.The operator stated that the stent had a quality issue and would not be charged for it.The device was stuck (locked up) in the catheter/resistance in the catheter.The catheter was flushed continuously with heparinized saline.The pipeline became stuck in the distal section of the catheter during delivery.The physician released the load (slack) in the system in an attempt to resolve the issue; however, this did not resolve the issue.There was no damage to the catheter or pushwire.Patient symptoms or complications associated with this event were blood vessel rupture and bleeding.The pipeline was used for an approved (on-label) indication.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysms on the right internal carotid artery: one at the posterior communicating artery segment and one at the ophthalmic artery segment with a max diameter of 10 mm anda 9 mm neck diameter.The landing zone was 2.5 mm distal and 4.7 mm proximal.The access vessel was the femoral artery with a diameter of 10 mm.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level was normal.The angiographic result post procedure that due to elevated intracranial pressure, the contrast agent could not go far.Ancillary devices include a navien 6f guide catheter, marksman microcatheter.Additional information was received reporting that the actions or interventions taken to resolve the ruptured aneurysm/bleeding included promptly filled spring coils, drilled holes for drainage, and relieved pressure.The procedure was completed with surgical intervention with drilling hole drainage and decompression.The cause of the resistance and rupture/bleed was unknown.It was unknown if the rupture/bleed was caused by or related to the resistance.
Additional Manufacturer Narrative
Product analysis: as found condition: the navien 072 catheter was returned for evaluation inside the inner pouch, biohazard bag and shipping box.Visual inspection/damage location details: the distal tip and marker band were examined, no damage was found.The navien body appeared to be kinked at 30.6cm and 49.0cm from the distal tip.No flash or voids molded were observed in the hub.Testing/analysis: the usable length of the navien catheter was measured to be within specifications.The navien 072 catheter was f lushed with water and found to be patent.The catheter was tested by running an in-house 0.050" mandrel through the catheter hub.The mandrel successfully passed through the catheter hub with no issues.However, it got stuck at 49.0cm from the distal tip.Conclusion: based on the analysis findings, the customer complaint was confirmed as the returned navien was found to be kinked.However, the cause of the resistance and damage could not be determined.It is possible that the severe vessel tortuosity contributed to the resistance during delivery.Since the marksman catheter was not returned, any contribution of the catheter to the resistance could not be assessed.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
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803.Note that the h.6.Codes have been updated to reflect the new information.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: 24060650
• Report Number: 2029214-2026-00068
• Device Sequence Number: 9495228
• Product Code: DQY
• 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,Followup
• Report Date (Section B): 05/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: RFX072-115-08MP
• Device Catalogue Number: RFX072-115-08MP
• Device Lot Number: B820990
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 05/14/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/25/2026; 05/27/2026
• Date Device Manufactured: 11/21/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female