MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number	105-5081-153
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
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 a solitaire stent met resistance in the proximal end of a rebar catheter and the stent was not moving forward.Another device was used to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of a middle cerebral artery (mca) occlusion stroke.Mca vessel diameter was 2.5 mm.It was noted the patient's vessel tortuosity was moderate.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).
Event or Problem Description
Additional information was received.The patient¿s baseline nihss was 6 and tici was 1.After thrombectomy, the patient¿s condition improved to a tici of 3 and an nihss of 5.The same solitaire was used to complete the procedure without replacement.During the procedure, strong resistance was encountered at the middle segment of the catheter, but there were no issues during microcatheter navigation.No kinks or damage were noted on either the catheter or the solitaire pushwire.The tip of the solitaire sheath was secured into the hub of the microcatheter.
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.
Additional Manufacturer Narrative
Product analysis as found condition: the rebar-18 catheter was returned for analysis within a shipping box, a sealed plastic pouch, an opened rebar-18 outer carton (b)(4), an opened rebar-18 inner pouch (b)(4), and within a dispenser coil.No solitaire returned.Damage location details: no damages were found with the rebar-18 catheter hub.No bends or kinks were found with the rebar-18 catheter body.The rebar-18 catheter distal tip was found to be in good condition.No other anomalies were observed.Testing/analysis: the rebar-18 catheter was flushed; water exited from the distal tip.Next the 0.021¿ mandrel was hydrated and delivered through the rebar-18 catheter hub, which exited out the distal tip without any issue.No resistance was able to be reproduced.Conclusion: based on the device analysis and reported information, the customer¿s ¿ catheter resistance¿ report could not be confirmed; however, the event could not be ruled out.No issues were encountered during testing.A few possible causes of ¿catheter resistance¿ include using incompatible devices, patient vessel tortuosity, guidewire or delivery system damage, and insufficient catheter flushing or lack of continuous flush; however, the root cause of ¿catheter resistance¿ was unable to be determined.The solitaire used in the procedure was not returned; in addition, no details were provided (lot number, ref number); therefore, compatibility could not be verified.Any contribution the solitaire had towards the resistance was unable to be confirmed.No defect was found with the rebar-18 catheter that would have contributed to the reported resistance.It was noted that the patient's vessel tortuosity was moderate.No mention of a continuous flush administered during the procedure was reported.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).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: REBAR
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 23087559
• Report Number: 2029214-2025-02044
• Device Sequence Number: 10502605
• Product Code: KRA
• UDI-Device Identifier: 00847536026834
• UDI-Public: (01)00847536026834(17)270225(10)D021433
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093750
• 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): 11/30/2025

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 Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: D021433
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 09/19/2025; 11/12/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 09/29/2025; 11/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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