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

Model Number	FA-55150-1030
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the treatment for a left internal carotid artery giant aneurysm using a pipeline embolization device, several complications occurred.The stent became stuck in the marksman microcatheter during deployment.After multiple attempts to re-sheath and release the stuck portion, the stent fell inside the aneurysm from its proximal part and subsequently shrank.Another flow diverter, surpass 5x30, was successfully deployed inside the pipeline.The catheter tip became entrapped, and catheter stretch occurred during removal, resulting in damage to the distal section.The pipeline became stuck in the middle section of the catheter during deployment, missed the landing zone, and was not implanted at the intended location.Migration of the pipeline after deployment was noted due to multiple attempts to release the stent from the microcatheter.Dual antiplatelet treatment was administered, and the angiographic result post-procedure was normal.The patient outcome was reported as alive with no injury.No patient complications have been reported as a result of this event.Ancillary devices: guide catheter guider softip 8f, guidewire synchro.
Additional Manufacturer Narrative
Continuation of d10: product id ped2-450-35 (b706758); product type: ; implant date ; explant date.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: 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: 21029397
• Report Number: 9617601-2024-00426
• Device Sequence Number: 9155923
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: 00836462014077
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: 05/05/2026
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 226389671
• 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: 12/21/2024
• Initial Report FDA Received Date: 12/27/2024
• Date Device Manufactured: 05/05/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male