MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number	FA-55160-1030
Medical Device Problem Codes	Unintended Movement (3026); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the pipeline encountered resistance in the marksman catheter resulting in unintended movement during deployment.  the patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the ophthalmic artery with a max diameter of 25 mm and a 10 mm neck diameter.The landing zone: distal: 3.5 mm and proximal 3.8 mm.  it was noted the patient's vessel tortuosity was severe.Dual antiplatelet treatment was administered.The pru level was standard.The angiographic result post procedure was normal.It was reported that the operator first placed the catheter fa-55160-1030 (224314029) to the distal end of the parent artery.The de ployment position and feel were normal.The operator first selected a ped-375-25 blood flow diversion dense mesh stent.After passing through the starting end of fa-55160-1030 (224314029), during the delivery of ped-375-25, the pushing resistance increased, causing the delivery catheter fa-55160 -1030 (224314029) fell into the aneurysm cavity along with a section of the stent during delivery, and repeatedly tried to push the catheter to the distal end of the parent artery, but failed.It was reported the pipeline became stuck (locked up) in the catheter or resistance was encountered in the middle of the catheter.The catheter was flushed continuously with heparinized saline.The pipeline did not become stuck.The catheter and pushwire were not damaged.The pipeline was not used for an indication that is off-label.The pipeline and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.2024-02-20 e1 (for, hcp, rep): additional information was received stating that the cause of the resistance was that the aneurysm path was tortuous, causing excessive resistance.Multiple pipelines were not used and had been removed.The pipeline was removed.The pipeline was not implanted at the intended location.The pipeline slipped from the distal end of the aneurysm.The tip of the catheter moved and slipped from the distal end of the aneurysm.2024-apr-07 (b)(4), email (for, rep, sdy): no new event information received.

• Brand Name: MARKSMAN
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20621050
• Report Number: 9617601-2024-00279
• Device Sequence Number: 18361331
• Product Code: KRA
• UDI-Device Identifier: 00847536026278
• UDI-Public: 00847536026278
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091559
• 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): 11/06/2024

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: 05/16/2025
• Device Model Number: FA-55160-1030
• Device Catalogue Number: FA-55160-1030
• Device Lot Number: 224314029
• 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: 02/04/2024
• Initial Report FDA Received Date: 11/06/2024
• Date Device Manufactured: 05/16/2022
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 50 KG