MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY

Catalog Number	PND6F070956M
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
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 medical procedure in the carotid artery using a neuron 6f 070 delivery catheter (neuron 070), a non-penumbra sheath, and a guidewire.It was noted that the patient's anatomy was tortuous.During the procedure, while advancing the neuron 070 into the patient, the physician experienced resistance and the neuron 070 became stuck in the pelvis.While removing the neuron 070 and sheath, the physician experienced resistance again and noticed that the distal length of the neuron 070 had fractured.It was reported that the physician successfully retrieved the fractured segment of the neuron 070.The procedure was completed using a new neuron 070 and a new non-penumbra sheath.
Event or Problem Description
The patient was undergoing a medical procedure in the carotid artery using a neuron 6f 070 delivery catheter (neuron 070), a non-penumbra sheath, and a guidewire.It was noted that the patient''s anatomy was tortuous.During the procedure, while advancing the neuron 070 into the patient, the physician experienced resistance and the neuron 070 became stuck in the pelvis.Therefore, the physician removed the sheath, neuron 070 and guidewire together.Upon removal, the physician noticed that the distal length of the neuron 070 had stretched and ovalized.The procedure was completed using a new neuron 070 and a new non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were updated on this follow-up #01 mfr report 3005168196-2024-00113: 1.Section b.Box 5.Describe event or problem 2.Section h.Box 6.Device code 1 3.Section h.Box 6.Patient code 1 evaluation of the returned neuron 070 could not confirm that the catheter was fractured on the distal length.Evaluation revealed that the catheter was ovalized and stretched on the distal length.This is likely the reported damage.If the neuron 070 is retracted against resistance at an angle, damage such as ovalization and stretching may occur.During evaluation, the returned neuron 070 was unable to be advanced through a demonstration neuron max.Further evaluation revealed kinks on the catheter shaft.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.

• Brand Name: NEURON 6F 070 DELIVERY CATHETER
• 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: 18986181
• Report Number: 3005168196-2024-00113
• Device Sequence Number: 18193872
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 814548010076
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K082290
• 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): 05/30/2024
• 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: 01/10/2026
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F00004963
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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 Age: 68 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005