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

Catalog Number	PNS5F130SIM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a carotid stenting procedure in the carotid artery using a neuron select catheter 5f (5f select), a neuron max 6f 088 long sheath (neuron max), and a guidewire.During the procedure, while advancing the 5f select through the neuron max, the physician observed under fluoroscopy that the distal segment of the 5f select fractured.The proximal segment of the 5f select was then removed.The physician then used a snare device to successfully remove the distal segment of the 5f select.The physician decided to abort the procedure and postponed it for another date.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and is being corrected on this follow-up # 1 mfr report: 3005168196-2024-00155.1.Section b.Box 1.Adverse event and/or product problem.2.Section d.Box 4.Unique identifier.3.Section h.Box 1.Type of reportable event 4.Section h.Box 6.Patient code 1.Evaluation of the first returned 5f select confirmed a fracture on the distal shaft.This damage typically occurs if the device is manipulated against resistance during use.The 5f select distal fractured segment was returned in several fragments.This was likely due to removal through the neuron max while snaring and due to handling on the back table.Therefore, the root cause of the fracture 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: 19149652
• Report Number: 3005168196-2024-00155
• Device Sequence Number: 7800624
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (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): 06/17/2024
• 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: 10/14/2024
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: H11951
• 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: 06/14/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005