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	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id sab-6-30 (lot: d014681); product id unk-nv-rebar (unknown); implant date n/a; explant date n/a product id unk-nv-rebar (unknown serial/lot); 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 whole brain angiography and thrombectomy operation for ischemic stroke m2 segment occlusion treatment.The site of intracranial vascular occlusion was determined by angiography.It was noted that the patient¿s vessel tortuosity was moderate.The stroke onset to reperfusion time was 40min it was reported that the guide sheath, neurovascular guidewire, thrombus aspiration catheter, rebar18 microcatheter, and intracranial vascular stent sab-6-30 were selected.After the preparation work was completed, the rebar 18 microcatheter was successfully put in place.The surgeon selected the intracranial vascular stent sab-6-30 and moistened it in vitro.During the delivery process of slowly pushing the stent, it was found that the resistance to pushing the stent gradually increased at the proximal section of the catheter, and finally the stent could not be pushed further.It was found that the tail of the stent was clogged at the tail of the microcatheter.The surgeon tried many times but failed to push it.Two new rebar18 microcatheters were used instead for delivery, but they could not be pushed in place.Because the patient was already in a coma and the situation was critical, a new sab-6-30 stent w as finally used instead, successfully pushed in place, and the thrombus was removed.After the operation, the surgeon thought that this situation had never occurred when using sab-6-30 before.After replacing the microcatheter, it still could not be pushed normally, and the surgeon filed a complaint that it was a product quality issue.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
Additional Manufacturer Narrative
B5.Updated with additional information received.D3/d4 updated based on additional information received.H6.Coding updated based on available information.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 patient's baseline nihss was 12 and post procedure tici nihss had improved to 3.The cause of the resistance was not determined.Continuous saline flush was administered and maintained during the procedure per the ifu.There was not kink/damage observed to the catheter(s) after removal.All the attempted rebar 18 microcatheters were from the same model/lot.It should be noted that per the ifu, the sab-6-30 is recommended for use with a catheter that has an inner diameter of 0.027 inches and is therefore not compatible/off label use with rebar 18 catheter which has an inner diameter of as it had a labeled inner diameter of 0.021 inches.

• Brand Name: REBAR
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; carretera san isidro, km 17; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; carretera san isidro, km 17; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22576412
• Report Number: 9612501-2025-01972
• Device Sequence Number: 15864771
• Product Code: KRA
• UDI-Device Identifier: 00847536026834
• UDI-Public: (01)00847536026834(17)250906(10)B622015
• 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
• Report Date (Section B): 08/22/2025

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: 09/06/2025
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: B622015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/22/2025
• Date Device Manufactured: 09/07/2023
• 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: 70 YR
• Patient Sex: Female