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

Model Number	FG13150-0615-2S
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that after deployment of the pipeline vantage with shield technology stent, resistance was met when advancing the phenom 27 microcatheter along the pipeline device wire, and the wire could not be further drawn into the catheter starting from the section with the ptfe sleeves, resulting in tension.The pushwire/capture coil stuck during retraction after the ptfe sleeves entered the catheter.The stent was implanted and the catheter and wire/tip coil were removed from the patient.No patient symptoms or complications were reported with this event.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was used for an approved indication (on-label).The pushwire was not rotated during removal.It is unknown if there was any damage to the catheter, pushwire, or capture coil.Ancillary devices include a 150 cm phenom 27 microcatheter.The patient is alive and there were no patient complications associated with this event.The lesion characteristic was an internal carotid artery.Vessel tortuosity was moderate.The catheter was flushed per ifu during the procedure.There was no friction or difficulty during delivery or positioning.The cause of the event was not determined.
Additional Manufacturer Narrative
H3: product analysis ¿as found condition: the pipeline vantage shield and the phenom 27 catheter were returned for analysis within shipping box; within an open ed pipeline vantage shield inner pouch; and within a dispenser coil.The pipeline vantage shield returned within the phenom 27 catheter.The pipeline vantage shield braid was not returned for analysis.Therefore, any contributing factors could not be assessed.¿damage location details: the pushwire was returned extending out from the hub.In addition, the tip coil was deployed from catheter distal tip.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, arms or with the proximal bumper.However, dried blood was present within the arms.No flash or voids molded were observed in the hub.The catheter body was found to be kinked at ~124.6cm from proximal end.The catheter tip, marker band were examined; and no damages were found.No other anomalies were observed.¿testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The pipeline vantage shield was pushed from catheter lumen without any issues.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 hub and tip with no issues; however, the resistance observed at the damaged location.¿conclusion: based on the analysis findings, the pipeline vantage and phenom 27 catheter were confirmed to have resistance as the pipeline vantage shield was returned within phenom 27 catheter.No defect was found with pushwire.The pipeline vantage shield braid was not returned for analysis.Therefore, any contributing factors could not be assessed.Resistance was observed at damage location.However, the root cause could not be determined.Possible causes include incompatible catheter, damaged catheter, burrs, bumps, kinks or other damage on ped or pushwire, frayed ends on braid, patient vessel tortuosity, user does not maintain continuous flush, and users pulls back on/torques wire while advancing ped in microcatheter.It appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline vantage shield through the phenom 27 catheter against resistance.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: 23535668
• Report Number: 9617601-2025-02691
• Device Sequence Number: 10187191
• Product Code: QJP
• UDI-Device Identifier: 00763000399689
• UDI-Public: (01)00763000399689(17)280326(10)230932598
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: FG13150-0615-2S
• Device Catalogue Number: FG13150-0615-2S
• Device Lot Number: 230932598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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