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

Model Number	105-5081-153
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 the surgeon planned to use a solitaire stent for thrombectomy.After the rebar microcatheter was in place, a 4-20 stent was delivered.However, significant resistance was encountered when the stent reached the middle of the microcatheter, making it impossible to advance.Retraction of the stent also encountered resistance.To ensure safety, the surgeon removed the stent and microcatheter as a whole.A guidewire was also felt to be stuck through the microcatheter, suggesting potential internal damage of the microcatheter.A new microcatheter was then used instead to complete the procedure.The reported device and any accessory devices were prepared and the catheter was 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 thrombus removal.It was noted the patient's vessel tortuosity was minimal.Access vessel was the femoral artery.
Additional Manufacturer Narrative
¿ updated b5, d9 ¿ h3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6: the evaluation codes have been updated for this event 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
Additional information was received.The patient¿s baseline status was tici 1 grade with an nihss score of 16, and post-thrombectomy, the condition improved to tici grade 2a with an nihss score of 5.The cause of the resistance encountered during the procedure was not determined.No kink or damage was observed on the catheter or the solitaire pushwire.The tip of the solitaire sheath was secured into the hub of the microcatheter.The guidewire used was not a medtronic product.
Additional Manufacturer Narrative
Product analysis as found condition: the rebar-18 micro catheter was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The solitaire fr 4-20 used during the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the rebar-18 micro catheter hub.The micro catheter body was found kinked at ~12.3cm from the distal end.No damages or irregularities were found with the distal tip or marker band.Testing/analysis: the rebar-18 micro catheter total length was measured to be ~161.1cm and the usable length was measured to be ~154.6cm, which is within specification (specification: total (ref) = 159.5cm, usable = 153.0cm ± 2.5cm).An in-house 0.021¿ mandrel was inserted into the hub, through the micro catheter and out the distal end with slight resistance encountered at the kinked location.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance during device delivery¿ and ¿catheter resistance during device retrieval¿ was confirmed as resistance was encountered at the kinked location.Possible causes for catheter kinking are patient vessel tortuosity, guidewire/delivery system removed aggressively, catheter entrapment or user advances/retrieves the device against resistance.Other possible causes for catheter resistance include, but not limited to, patient vessel tortuosity, insufficient continuous flush, solitaire device damage, or insufficient device hydration.As the solitaire fr device used during the event was not returned, any contribution of the solitaire device towards resistance could not be determined.The solitaire fr 4-20 is compatible for use with the rebar-18 as the fr-4-20 requires a minimal inner diameter of 0.021¿.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: 23631354
• Report Number: 2029214-2025-02478
• Device Sequence Number: 10477743
• Product Code: KRA
• UDI-Device Identifier: 00847536026834
• UDI-Public: (01)00847536026834(17)261007(10)B799632
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/27/2026

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: B799632
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 01/13/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/17/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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: 50 YR
• Patient Sex: Male