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

Catalog Number	PNS5F120BER
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	02/21/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient, was undergoing a thrombectomy procedure.To treat a total carotid artery occlusion using a neuron select catheter 5f (5f select), a neuron max 6f 088 long sheath (neuron max) and guidewire.It was noted, that the patient anatomy was tortuous.During the procedure, while attempting to advance the 5f select through the carotid artery, the physician experienced resistance and fractured the distal length of the 5f select.The procedure was ended at this point.The patient was then taken to surgery and the fractured segment of the 5f select was removed successfully.The patient, then expired the next day, due to the total carotid artery occlusion.
Additional Manufacturer Narrative
Ischemia and death are included as possible complications in the instructions for use (ifu) for the neuron intracranial access system.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up # 1 mfr report: 1.Section d.Box 4.Unique identifier.2.Section h.Box 6.Patient code 1.Evaluation of the returned 5f select confirmed that the catheter was fractured.This type of damage typically occurs if the device is manipulated or torqued against resistance during advancement.Based on the reported event, the tortuous patient anatomy may have contributed to some resistance during the procedure.Further evaluation revealed an ovalization on the catheter shaft.This damage was incidental to the reported complaint and the root cause could not be determined.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.

• 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: 18956277
• Report Number: 3005168196-2024-00093
• Device Sequence Number: 9291353
• Product Code: DQY
• UDI-Device Identifier: 00814548010182
• UDI-Public: 00814548010182
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (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): 06/28/2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2025
• Device Catalogue Number: PNS5F120BER
• Device Lot Number: H00000404
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 85 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005