MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PHENOM CATHETER; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	FG11150-0615-2S
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil experienced resistance in the phenom 17 catheter.The patient was undergoing treatment for a cerebral aneurysm.The access vessel was the internal carotid artery, which was 4mm in diameter.The patient's blood flow was normal, and their vessel tortuosity was moderate.It was reported that the first coil was successfully deployed and detached without any issues.However, when inserting the second coil of the same product, it could not be pushed out from the catheter.Additionally, it became impossible to retract the coil, leading to the removal of the catheter along with the coil.Access to the aneurysm was reestablished using a different product, and the subsequent embolization with coils was completed without any further issues. the patient did not experience any health damage.The devices were prepared and flushed according to the instructions for use (ifu).
Additional Manufacturer Narrative
Continuation of d10: product id fc-5-15-3d (229830258); product type: ; implant date n/a; explant date n/a.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
H3: device received, analysis is in progress.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 received reported that the cause of the resistance was not known.It was assumed that the resistance was in the distal segment of the catheter because it occurred after it was taken out into the aneurysm and put back.The coil had come out of the introducer sheath smoothly.A continuous saline flush had been administered and maintained as indicated in the ifu.There was no kink/damage observed to the coil or catheter.
Additional Manufacturer Narrative
Product analysis: the phenom-17 catheter, and the framing coil were returned for analysis within a shipping box, within a resealable plastic biohazard pouch, and the framing coil was within an introducer sheath.Damage location details: no damage was found to be the phenom-17 catheter body; however, dried blood was found throughout the catheter body (proximal-distal portion).No damage or irregularities were observed with the phenom-17 distal tip or marker bands.Testing/analysis: the phenom-17 catheter body total length was measured to be ~156.2cm, and the usable length was measured to be ~150.1cm, which was found to be within specification (specification: total (ref) = 156.5cm, usable: 150.0cm ± 1.5cm).During testing, the phenom-17 was cut open and found to be full of dried blood from the distal segment to the proximal segment.While opening the phenom-17 catheter body, the inner liner was found to be damaged (liner delamination/peeling) at ~38,0cm from the hub.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): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22150968
• Report Number: 9617601-2025-00520
• Device Sequence Number: 7639167
• Product Code: QJP
• UDI-Device Identifier: 00763000399665
• UDI-Public: (01)00763000399665(17)280325(10)230932592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/11/2025

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: FG11150-0615-2S
• Device Catalogue Number: FG11150-0615-2S
• Device Lot Number: 230932592
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 07/15/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/15/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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: Unknown