MAUDE Adverse Event Report: MEDTRONIC DOMINICANA REBAR; CATHETER, CONTINUOUS FLUSH

Model Number	105-5081-153
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
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 a solitaire fr stent became stuck during use.The patient was undergoing thrombectomy surgery for treatment of a ischemic stroke in the left internal carotid artery.It was noted the patient's vessel tortuosity was normal.Intravenous tissue plasminogen activator (iv tpa) was not contraindicated in this case.The procedure involved one pass with the device.The stroke onset to reperfusion time was 107 minutes.It was reported that the solitaire fr stuck in patient's body with the microcatheter, and retrieval failed.After replacing the stent, the procedure was completed successfully.No patient symptoms or complications were associated with this event.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Additional information was received.The lesion was a left internal carotid artery aneurysm with terminal occlusion.The vessel tortuosity was normal.The reported statement of ¿the solitaire fr stuck in patient¿s body with the microcatheter, and retrieval failed¿ was clarified to be as follows: after the solitaire fr was pushed out from the microcatheter, repositioning was desired due to suboptimal positioning; however, during retrieval, the device could not be retrieved into the microcatheter.There was no friction or difficulty during delivery or positioning.There was catheter resistance in the distal section.The entire system was withdrawn into the intermediate catheter.A continuous saline flush was administered and maintained as indicated in the ifu.The rebar 18 catheter was used (105-5081-153, lot #: 0231075206).The causes or contributing factors for the resistance were not identified.The patient's baseline and post-thrombectomy condition is unknown.

• Brand Name: REBAR
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 25187452
• Report Number: 9612501-2026-01365
• Device Sequence Number: 21506083
• Product Code: KRA
• UDI-Device Identifier: 00763000412487
• UDI-Public: (01)00763000412487(17)270407(10)0231075206
• 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
• Report Date (Section B): 05/15/2026

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: 0231075206
• 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: 04/17/2026
• Initial Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 04/07/2025
• 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: 82 YR
• Patient Sex: Female