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

Catalog Number	PNS5F130SIM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ischemia Stroke (4418); Foreign Body Embolism (4439)
Date of Event	02/05/2024
Type of Reportable Event	Death
Event or Problem Description
The patient was undergoing a diagnostic procedure using a neuron select catheter 5f (5f select), a non-penumbra sheath introducer and guidewire.During the procedure, the physician catheterized the right common carotid artery via radial access using the 5f select, sheath introducer and guidewire.While removing the guidewire to inject contrast, the physician noticed the distal length of the 5f select fractured.While attempting to remove the fractured 5f select with a snare device, the physician further fractured the distal length of the 5f select.A fractured piece of the 5f select migrated to the right m2 segment of the middle cerebral artery (mca) which then began to thrombose.The physician attempted to remove the fractured piece using different techniques but was unsuccessful.The procedure ended at this point.The patient was then transferred to the intensive care unit (icu) with a malignant infarction in the right mca.Due to the poor prognosis, a decompressive craniectomy was offered; however, the family rejected it due to the serious disability in which the patient would be left in.The patient later expired.The patient¿s cause of death was reported to be a stroke.The exact date of death is unknown.It was reported that the physician fractured two new 5f select upon opening their respective package.The fracture was reported to be at the same location as the one previously used in the patient.It was also reported that the day after the procedure, the hospital staff fractured another 5f select at the same location as the previous 5f selects.
Additional Manufacturer Narrative
The product was not returned for evaluation.Emboli, neurological deficits including stroke and death are included as possible complications in the instructions for use (ifu) for the neuron intracranial access system.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
Additional Manufacturer Narrative
Corrections: please note that the following sections are being corrected on this follow-up: 1.Section b5.Describe event or problem.2.Section g4.Date received by manufacturer (mm/dd/yyyy).The original event description included reference to three additional neuron 5f select catheters (5f select).Additional information confirmed that the three additional 5f selects fractured during a bench-top evaluation by hospital personnel one-day after the event.The bench-top evaluation was not associated with a patient procedure.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a diagnostic procedure using a neuron select catheter 5f (5f select), a non-penumbra sheath introducer (6f prelude) and guidewire (0.035" terumo).During the procedure, the physician catheterized the right common carotid artery via radial access using the 5f select, sheath introducer and guidewire.While removing the guidewire to inject contrast, the physician noticed the distal length of the 5f select fractured.While attempting to remove the fractured 5f select with a snare device, the physician further fractured the distal length of the 5f select.A fractured piece of the 5f select migrated to the right m2 segment of the middle cerebral artery (mca) which then began to thrombose.The physician attempted to remove the fractured piece using different techniques but was unsuccessful.The procedure ended at this point.The patient was then transferred to the intensive care unit (icu) with a malignant infarction in the right mca.Due to the poor prognosis, a decompressive craniectomy was offered; however, the family rejected it due to the serious disability in which the patient would be left in.The patient later expired.The patient¿s cause of death was reported to be a stroke.The exact date of death is unknown.

• 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: 18857416
• Report Number: 3005168196-2024-00074
• Device Sequence Number: 20892674
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 814548010236
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/07/2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2024
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: F104409
• Was Device Available for Evaluation?: No
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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; Death
• Patient Age: 66 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005