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

Model Number	105-5081-153
Medical Device Problem Codes	Retraction Problem (1536); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor complained the device was very sticky and hard to push up prior to first deployment with the device.It was determined the device was oversized for the aneurysm.The doctor tried to recapture the device however was unable to fully recapture the device into the rebar 18.The rebar 18 and device were removed from the patient.On the sterile field the doctor tried to pull the device back into the rebar 18 again and we visually saw the rebar accordion on itself.The doctor for their own knowledge opened a headway 21 and the device still couldn¿t be pushed through the headway 21.Additional information received reported the device got ¿stuck¿ in the rebar during retraction.The doctor opened the artisse and when decided to use another size, he was resheating the device in the rebar.It was at that point he felt it got stuck.When he felt he could not resheat completely, he decided to pull back the entire system, rebar and artisse (inside).On the table, outside the patient, we saw the accordion effect at the distal part of the rebar.New device and new rebar were chosen and all went fluent.
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: vis (m-78210), 203cm ruler (m-83361) as found condition: the artisse device, a rebar-18 catheter, and a (microvention) headway 21 catheter were returned within a shipping box and a tyvek bio-pouch.Visual inspection/damage location details: the artisse device was returned within the headway 21 catheter.The artisse pusher was found extending out from within the headway 21 catheter hub for ~56.7cm.The headway 21 catheter hub appears to be in good condition.The headway 21 catheter body was found kinked at ~2.0cm from the catheter distal tip.The headway 21 catheter distal tip appears to be in good condition.The artisse implant aperture braids were found bent and broken.No damage was found with the rebar-18 catheter hub.The rebar-18 catheter body was found kinked at ~36.3cm from the catheter distal tip.The rebar-18 catheter distal tip was found damaged.Testing/analysis: the artisse device was pushed out from within the headway 21 catheter without issue.The artisse device was backloaded into the rebar-18 catheter distal tip for resheathing testing.During resheathing, the artisse implant was observed to be hooking and catching on the rebar-18 catheter distal tip causing the distal ~14.5cm of the rebar-18 catheter to become wavy.The artisse device could not be resheathed within the rebar-18 catheter.An in-house 0.021¿ mandrel was inserted through the rebar-18 catheter and headway 21 catheter without issue.Conclusion: based on the device analysis and reported information, the customer¿s ¿failure to resheath¿ and ¿resistance during retrieval¿ reports were confirmed.It is likely that the damage found with the returned artisse implant braids contributed to the difficult resheathing, subsequently damaging the rebar-18 catheter distal tip.However, the cause of the implant braid damage could not be determined.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.
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 received reported site has completed the device identification crf reporting artisse intrasaccular device isf-060-040 (b702305) was not implanted due to ' instructions for use (ifu) sizing not adequate'.Site reported "a lack of clear guidelines for use of biaxial access system was used instead of triaxial¿."used biaxial instead of triaxial access.Ifu is inconsistent, stating to use "standard technique" and "triaxial system".
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 received reported that rebar momentarily collapsed.The rebar "zig-zagged", but was still able to be used to retrieve the artisse.It was also alleged that there was unclear ifu language for access.The site had used biaxial instead of triaxial access.However, the ifu was inconsistent, stating to use "standard technique" and "triaxial system" even though biaxial was standard technique at their site.
Event or Problem Description
Information received reported that the patient was undergoing surgery for treatment of a saccular, left side aneurysm at the mca bifurcation with a max diameter of 4.9 mm and a 2.7 mm neck diameter.Dual antiplatelet treatment (dapt) was administered.One detachment attempt was made on the replacement artisse implant device.After detachment, the placement of the device was satisfactory and the device had adequate conformability to the shape of the treated aneurysm.
Additional Manufacturer Narrative
B5 updated h3 analysis results were provided previously h6 code added to reflect previously reported allegation 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): 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: 22120472
• Report Number: 9612501-2025-01405
• Device Sequence Number: 6950755
• Product Code: KRA
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/02/2026

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 Expiration Date: 05/02/2026
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: 0228726721
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 08/12/2025; 10/10/2025; Not provided; 06/10/2026
• Initial Report FDA Received Date: 05/31/2025
• Supplement Report FDA Received Date: 07/10/2025; 09/05/2025; 11/07/2025; 05/13/2026; 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 104 KG