MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 5F; DQY

Catalog Number	PNS5F130SIM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2024-00354.
Event or Problem Description
The patient was undergoing a medical procedure in the internal carotid artery (ica) using a neuron select catheter 5f (5f select) and a guidewire (0.035 inch) via a transradial approach.It should be noted that the patient's anatomy was tortuous.During the procedure, while advancing the 5f select to the target location, the physician noticed that there was no movement of the 5f select under fluoroscopy.The physician then noticed that the 5f select was fractured at the distal length.Therefore, the fractured segment of the 5f select was removed from the patient using a snare device.The physician then advanced a second 5f select into the target location.After advancing the 5f select to the target location, the physician observed under fluoroscopy that the 5f select was fractured into three pieces at the distal length.Therefore, the fractured segments of the 5f select were removed from the patient using the same snare device.At this point, the procedure was converted into femoral access using a non-penumbra catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron select catheter 5f (5f select) confirmed that the catheter was fractured.Based on the reported event, this damage likely occurred due to the 5f select being advanced against resistance.The reported tortuous anatomy may have contributed to resistance during the procedure.The distal fractured segment was not returned for evaluation.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns please note that the following sections were updated on this follow up #1 mfr report: 1.Section d.Box 1.Manufacturer email 2.Section d.Box 8.Was this device serviced by a third party? 3.Section g.Contact information 4.Section h.Box 6.Component code 1 5.Section h.Box 6.Health effect impact code 1 & health effect impact code 2.

• Brand Name: NEURON SELECT CATHETER 5F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20534217
• Report Number: 3005168196-2024-00353
• Device Sequence Number: 8284220
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K083125
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025
• Report Date (Section F): 01/01/2005

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 Expiration Date: 09/29/2024
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: H11906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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 Age: 52 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005