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

Catalog Number	PND6F0701058M
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using a neuron 6f 070 delivery catheter (neuron 070), a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter and a balloon device.During the procedure, the neuron max was advanced to the cervical internal carotid artery (ica) and the neuron 070 was advanced to the cavernous segment.While introducing a non-penumbra microcatheter and a balloon device into the neuron 070, resistance was encountered and the proctor physician noticed that the neuron 070 was fractured at the proximal end outside of the patient.Therefore, the neuron 070 was removed.The procedure was completed using a new neuron 070, the same neuron max, the same microcatheter, and the same balloon device.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following sections were updated on this follow-up #01 mfr report: 3005168196-2023-00415.Section b.Box 5.Describe event or problem; section h.Box 6.Device code 2.Evaluation of the returned neuron 070 could not confirm that the catheter was fractured on the proximal end.Evaluation revealed that the neuron 070 was kinked underneath the strain relief.This is likely the reported damage.If the neuron 070 is advanced against resistance, damage such as a kink may occur.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed additional kinks and ovalization along the length of the catheter shaft.This damage was incidental to the reported complaint and likely 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.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using a neuron 6f 070 delivery catheter (neuron 070), a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter and a balloon device.During the procedure, the neuron max was advanced to the cervical internal carotid artery (ica) and the neuron 070 was advanced to the cavernous segment.While introducing a non-penumbra microcatheter and a balloon device into the neuron 070, resistance was encountered and the proctor physician noticed that the neuron 070 was kinked at the proximal end outside of the patient.Therefore, the neuron 070 was removed.The procedure was completed using a new neuron 070, the same neuron max, the same microcatheter, and the same balloon device.There was no report of an adverse effect to the patient.

• 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: 17671956
• Report Number: 3005168196-2023-00415
• Device Sequence Number: 20341608
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 814548010052
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/06/2023
• 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: 12/05/2025
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F00004474
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005