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	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id sab-6-30 (lot: b731631).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 a saccular, unruptured carotid artery aneurysm with an unknown diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.The access vessel was the femoral artery, with 6mm diameter.It was reported that during the aneurysm embolization process, when the surgeon was deploying the solitaire ab stent, the stent could not be pushed out of the rebar catheter.The surgery was completed after replacing the catheter and stent.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 aneurysm diameter was 4mm.The resistance was in the middle of the catheter.There was no damage observed to the catheter or stent after removal.
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
H3.Product analysis: equipment used: video inspection system (m-85519), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition: the rebar 18 catheter was returned for analysis with a solitaire ab 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 was flattened from ~1.0cm to ~18.0cm 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.In this event, the likely root cause of the resistance complaint was that the rebar 18 catheter was incompatible with the solitaire ab 6-30 stent device, as it has a labeled inside diameter (id) of 0.021 inches.Per the solitaire ab instructions for use (ifu): ¿solitaire ab 6-30 should be delivered through a catheter with a minimum inside diameter (id) of 0.027 inches.¿ h6.Coding updated based on additional information received.***mdr decision corrected too not reportable.The catheter resistance did not occur with use of a solitaire fr, during a mechanical thrombectomy procedure, and occurred during delivery rather than retrieval.No additional supplemental reports are required unless additional information received indicates a reportable 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
Mdr decision corrected too not reportable.The catheter resistance did not occur with use of a solitaire fr, during a mechanical thrombectomy procedure, and occurred during delivery rather than retrieval.No additional supplemental reports are required unless additional information received indicates a reportable event.

• 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: 22532176
• Report Number: 2029214-2025-01621
• Device Sequence Number: 7487883
• Product Code: KRA
• UDI-Device Identifier: 00847536026834
• UDI-Public: (01)00847536026834(17)260522(10)B736238
• 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): 09/22/2025

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: 05/22/2026
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: B736238
• 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: 07/18/2025; 08/26/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/15/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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