MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV PHENOM CATHETER; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	FG15150-0615-1S
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline's delivery rod became stuck at the distal end of the phenom microcatheter and could not be withdrawn.The patient was undergoing aneurysm blood flow-diverting stent implantation surgery.It was noted the patient's vessel tortuosity was normal.The access vessel was the right femoral artery with a diameter of 8 mm.It was reported that a blood flow-diverting stent implantation was performed for an aneurysm in the c6 segment of the internal carotid artery.After the microcatheter was positioned, a ped2-425-25 was successfully deployed.After stent deployment, the delivery rod was retrieved through the phenom 27 microcatheter; however, the delivery rod became stuck at the distal end of the microcatheter and could not be withdrawn.The system was removed entirely from the patient, and another microcatheter was used to continue the subsequent procedure.There was catheter resistance in the distal section.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id ped2-425-25 (unknown).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
B5: additional information added to event summary.H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 was received.The causes or contributing factors for the event were not identified.
Additional Manufacturer Narrative
H2/h6: the correct fdm/fdr/fdc codes were updated and applied.H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 was received.The causes or contributing factors for the event were not identified.Additional information was received.A continuous catheter flush was administered throughout the procedure.The pipeline shield braid was not returned because it is inside the patient's body.
Additional Manufacturer Narrative
B5: additional information added to event summary.H6: coding update based on additional information.H3: product analysis ¿ as found condition: the pushwire was returned stuck at the distal tip of the phenom 27 catheter, inside the inner pouch, bio-hazard bag, and shipping box.The pipeline flex shield braid was not returned.¿ damage location details: the tip coil appeared to be stretched.The distal and proximal dps restraints were intact.The dps sleeves showed no signs of damage and were found to be intact.The distal hypotube appeared to be stretched, but the ptfe shrink tubing remained intact.No defects were found in the distal marker, re-sheathing marker, resheathing pad, or proximal bumper.An examination of the catheter tip and marker revealed no damage.The catheter body was accordioned between 6.2 cm and 12.3 cm from the distal tip.No other anomalies were noted.¿ testing/analysis: the pushwire was pushed out from the catheter lumen with difficulty.The total and usable lengths were measured and found to be within specifications.The catheter was flushed with water and was found to be patent.An in-house 0.026¿ mandrel was then tested by running it through the catheter hub without issue; resistance was observed at the damaged locations.¿ conclusion: based on the returned devices, the customer complaint was confirmed, as the pushwire was found stuck at the distal tip of the phenom 27 catheter.The observed damage to the catheter (accordioning), tip coil (stretching), and the hypotube (stretching) suggests that high force was probably applied.This damage may have occurred when the customer attempted to retrieve the pushwire through the catheter against resistance.Possible causes of the resistance include vessel tortuosity and the lack of a continuous flush with heparinized saline during delivery.The customer indicated that the vessel tortuosity was normal, ruling it out as a potential cause.However, the customer did not report whether a continuous flush was used; therefore, it could not be ruled out as a possible cause.In the event, the lack of continuous flush may have contributed to the resistance during retrieval.The phenom 27 catheter is compatible for use with the pipeline flex shield delivery system.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: PHENOM CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• 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: 24626689
• Report Number: 9617601-2026-01868
• Device Sequence Number: 9067857
• Product Code: QJP
• UDI-Device Identifier: 00763000399702
• UDI-Public: (01)00763000399702(17)280709(10)231783413
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151638
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/22/2026

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: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: 231783413
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/08/2026; 04/24/2026; 05/21/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/14/2026; 04/21/2026; 05/21/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Female