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 Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis ¿ as found condition: the pipeline flex shield embolization device and phenom 27 catheter were returned for analysis within shipping box; within a plastic bio-pouch; and within an opened pipeline flex shield and phenom 7 inner pouches.The pipeline flex was returned outside the phenom 27 catheter.¿ damage location details: no bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the tip coil, distal marker, re-sheathing marker, pads or with the proximal bumper.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The pipeline flex shield braid ends were found to be fully opened and damaged.No flash or voids molded were observed in the hub.The catheter body was found to broken/separated at ~157.5cm from proximal end.The catheter tip, marker band were examined; and was found to be flattened.No other anomalies were observed.¿ testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and water exited out of the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter catheter hub and tip with no issues; however, the resistance observed at the damaged location.¿ conclusion: based on the analysis findings, the pipeline flex shield and phenom 27 catheter were confirmed to have resistance during delivery as the pipeline flex braid and phenom 27 catheter were found to be damaged.Possible causes include patient vessel tortuosity, flush rate too low, catheter damage or device damage, guidewire or delivery system damage, material occludes catheter, insufficient catheter flushing or lack of continuous flush, insufficient guidewire or delivery system hydration.It was noted the patient's vessel tortuosity was normal and a continuous saline flush was administered and maintained as indicated in the ifu.Which eliminates these factors out as potential causes.However, the root cause could not be determined.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 pipeline experienced resistance within a phenom catheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm located on the c5 segment with a max diameter of 3.2 mm and a 2.1 mm neck diameter.The patient has a distal landing zone of 3.78 mm and a proximal of 4.22 mm.It was noted the patient's access vessel diameter on the femoral artery is 8.9 mm and vessel tortuosity was normal.It was reported that after advancing the microcatheter, there was resistance during stent delivery, and it could not be positioned c orrectly.After removing both the stent and the microcatheter together outside the body, it was observed that the stent's tip end was frayed and the microcatheter's tip end also showed abnormalities.Devices were flushed and prepped as indicated by the ifu.No patient symptoms or complications were associated with this event.Additional information received.The cause of the resistance and damage were not determined.There was no device jump or catheter tip movement during deployment.A continuous saline flush was administered and maintained as indicated in the ifu.

• 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: 24821348
• Report Number: 9617601-2026-02350
• Device Sequence Number: 18549426
• Product Code: QJP
• UDI-Device Identifier: 00763000399702
• UDI-Public: (01)00763000399702(17)280123(10)230529158
• 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
• Report Date (Section B): 04/08/2026

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: 230529158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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 Sex: Unknown