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	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id sfr-6-30 (d026266); 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.
Event or Problem Description
Medtronic received a report that the patient was undergoing treatment of intracranial thrombectomy for an internal carotid artery ischemic stroke.It was noted that the patient's vessel tortuosity was minimal.No iv tpa was contraindicated, and null number.The stroke onset to reperfusion time was unknown.The access vessel was the femoral artery, with 6mm diameter.It was reported that during the thrombectomy process, after the rebar microcatheter was in place, the surgeon was trying to deliver the thrombectomy solitaire fr stent, but the stent could not be pushed out of the catheter.After repeated attempts, it still could not be pushed out.They replaced it with another product and completed the surgery.The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
Event or Problem Description
Additional information received reported the patient was undergoing thrombectomy to treat an internal carotid artery (ica) occlusion.Patient's vessel tortuosity was moderate.The devices were prepared as indicated in the instructions for use (ifu).The resistance occurred in the middle segment of the rebar catheter.It was noted that continuous saline flush was administered and maintained per ifu.There was no kink of other damage observed to the catheter or solitaire.The tip of the solitaire sheath was secured in the hub of the microcatheter.The cause of the resistance was not determined.The patient did not have any symptoms complications associated with this event.The patient was discharged and experiencing normal recovery.Stroke onset to reperfusion time was 8 hours.
Additional Manufacturer Narrative
B5 updated with additional information received.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 micro catheter was returned for analysis within a shipping box, within a sealed plastic biohazard pouch and outside its returned dispenser coil.The solitaire fr revascularization device used during the event was not returned for a nalysis.Visual inspection/damage location details: no damages or irregularities were found with the rebar-18 hub.The micro catheter body was found flattened, kinked, and stretched between ~129.0cm and ~158.6cm from the proximal end (figures d, e).The micro catheter was also found kinked at ~1.4cm from the distal end (figure f).No damages or irregularities were found with the distal tip or marker bands.Testing/analysis: the rebar-18 micro catheter total length was measured to be ~161.8cm and the usable length was measured to be ~155.3cm, 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 and became stuck at the proximal damaged location.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was confirmed.The likely cause of the resistance is the rebar-18 micro catheter is not compatible for use with sfr-6-30 per instruction for use (minimum: 0.027¿).The rebar-18 micro catheter has an inner diameter of 0.021¿.Other possible contributors of failure are damaged catheter, patient vessel tortuosity, user does not maintain continuous flush, user does not maintain correct flush rate or rhv loose during delivery.The micro catheter was found kinked/flattened/stretched.Possible causes for catheter damage are patient vessel tortuosity, guidewire/delivery system removed aggressively, incompatible device used, catheter entrapment or user advances/retrieves the device against resistance.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: 22531867
• Report Number: 2029214-2025-01620
• Device Sequence Number: 12766768
• Product Code: KRA
• UDI-Device Identifier: 00847536026834
• UDI-Public: (01)00847536026834(17)260415(10)B718493
• 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): 09/09/2025

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: 04/15/2026
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: B718493
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 09/03/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/12/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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: 65 YR
• Patient Sex: Male