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	07/01/2025
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 patient was undergoing treatment for an ischemic stroke; acute large artery occlusion located at left internal carotid artery.It was noted that the patient's vessel tortuosity was normal. the iv tpa was not contraindicated.No    it was reported that the surgeon used an sfr stent for thrombectomy.During delivery, after the stent entered the microcatheter, it could not be pushed forward and encountered resistance in the middle section of the rebar catheter .The vessel was not tortuous.After the surgeon replaced the stent and the catheter, the procedure was successfully completed and the patient was not injured.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.
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
Additional information was received stating that the cause of the resistance was not determined.No kink/damage to the stent and catheter was observed after removal.The patient is in good condition and has been discharged.
Additional Manufacturer Narrative
B5 updated with additional information received.H3.Product analysis: equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition: the rebar 18 catheter was returned for analysis with a solitaire fr 6-30 stent device stuck inside, in a biohazard bag and a shipping box.Damaged location details: the rebar 18 catheter tip and marker were examined; no damages were found.The catheter body kinked at ~3.0cm from the distal tip and was bent at ~7.5cm to ~8.0cm from the distal tip.No voids or flashes were found on the catheter hub.No other anomalies were found.Testing/analysis: the rebar 18 catheter¿s total and usable lengths were measured within specifications.The catheter was flushed with water and found patent.It was tested by running an in-house 0.021-inch mandrel through the catheter hub without issues; however, resistance was observed along the damaged location.Conclusion: based on the reported information and device analysis, the customer¿s ¿catheter resistance¿ complaint was confirmed, as the returned rebar 18 catheter was kinked and bent.In this event, the root cause of the resistance complaint was that the rebar 18 catheter was incompatible with the solitaire fr 6-30 stent device, as it has a labeled inside diameter (id) of 0.021 inches.Per the solitaire fr instructions for use (ifu): ¿solitaire fr 6-30 should be delivered through a catheter with a minimum inside diameter (id) of 0.027 inches.¿ h6.Coding updated based on analysis findings.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 received reported the tip of the solitaire sheath was secured in the catheter hub.There was no kink/damage observed to the solitaire pushwire during use.

• 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: 22423488
• Report Number: 2029214-2025-01525
• Device Sequence Number: 6978961
• Product Code: KRA
• UDI-Device Identifier: 00847536026834
• UDI-Public: (01)00847536026834(17)261007(10)B799504
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2025

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: B799504
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 08/15/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/06/2025; 09/05/2025
• 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: 46 YR
• Patient Sex: Female