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	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient was undergoing treatment for a saccular, unruptured left middle cerebral artery, m1 segment aneurysm with a max diameter of 3.7*2.8 mm and a 3.4 mm neck diameter.The landing zone was 2.0 mm distally and 2.5 mm proximally.It was noted that the patient's vessel tortuosity was minimal.Dual antiplatelet treatment (dapt) was administered.The pru level was unknown.It was reported that the phenom 27 microcatheter was positioned, when deploying the ped-250-14, approximately one third of the stent was pushed out, due to the steep angulation, stent deployment was difficult and slight slippage occurred.When preparing to retrieve the stent for redeployment, the stent could not be retrieved; multiple attempts failed to bring it back into the microcatheter.After the microcatheter was removed for inspection, damage to the stent push rod was found, which was stuck at the tip end of the microcatheter.The whole system was removed.Another phenom 27 was used instead and positioned, then a ped-250-16 was used instead, which was successfully deployed with good positioning, and the procedure was completed.The postoperative angiography showed contrast retention within the aneurysm, with all branch vessels remaining normal.The pipeline was used for an indication that is approved (on-label).The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
Additional Manufacturer Narrative
Continuation of d10: product id: ped-250-14 (d079161).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 reporting that no causes or contributing factors for the stent could not be retrieved or damage were identified.The catheter resistance was noted in the distal section.A continuous saline flush was administered and maintained as indicated in the ifu.No kink/damage to the catheter observed after removal.The stent damage observed was, "slight deformation of the distal tip, and fracture of the push rod." no friction or difficulty during delivery or when positioning.The pipeline did not jump during deployment.Only one pipeline was used during the procedure.The tip of the catheter was not under stress.The tip of the catheter did not move during deployment.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.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 CA 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc CA 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 24662640
• Report Number: 2029214-2026-00497
• Device Sequence Number: 21143078
• Product Code: QJP
• UDI-Device Identifier: 00763000399702
• UDI-Public: (01)00763000399702(17)280805(10)231973615
• 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
• Report Date (Section B): 04/29/2026

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: 231973615
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 08/05/2025
• 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 Age: 41 YR
• Patient Sex: Female