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

Catalog Number	BMK6F95BER120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
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.
Event or Problem Description
The patient was undergoing a medical procedure in the right middle cerebral artery (mca) using a neuron select catheter 5f (5f select), a benchmark 6f 071 delivery catheter (benchmark), a flow diverter, and a guidewire.It was noted that the patent's anatomy was tortuous.During the procedure, the physician advanced the 5f select using the benchmark via right radial access.The 5f select could not advance further up the right common carotid artery (cca) due to the benchmark not being able to achieve a stable position.Therefore, the physician decided to remove the 5f select and benchmark to continue the procedure via right femoral access.Upon removal, it was noticed that the distal length of the 5f select was missing and had fractured in the radial artery.The physician used a stent retriever to successfully remove the distal fragment of the 5f select.The procedure was completed using a new 5f select and a new benchmark via right femoral access.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01 mfr report: 1.Section b.Box 5.Describe event or problem.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 unrestrained against resistance.Based on the reported event, the patient anatomy was tortuous and may have contributed to resistance during the procedure.Further evaluation revealed a kink on the distal fractured segment.This damage was incidental to the reported complaint and likely occurred during snaring of the device.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.
Event or Problem Description
The patient was undergoing a medical procedure in the right middle cerebral artery (mca) using a neuron select catheter 5f (5f select), a benchmark 6f 071 delivery catheter (benchmark), a flow diverter, and a guidewire.It was noted that the patient''s anatomy was tortuous.During the procedure, the physician advanced the 5f select using the benchmark via right radial access.The 5f select could not advance further up the right common carotid artery (cca) due to the benchmark not being able to achieve a stable position.Therefore, the physician decided to remove the 5f select and benchmark to continue the procedure via right femoral access.Upon removal, it was noticed that the distal length of the 5f select was missing and had fractured in the radial artery.The physician used a stent retriever through a velocity delivery microcatheter (velocity) to successfully remove the distal fragment of the 5f select.The procedure was completed using a new 5f select and a new benchmark via right femoral access.There was no report of an adverse effect to the patient.

• 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: 19542264
• Report Number: 3005168196-2024-00220
• Device Sequence Number: 7681213
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/07/2024
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2024
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F107082
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005