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

Catalog Number	PNS5F130SIM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure to perform angiography using a neuron select catheters 5f (5f select) and a non-penumbra sheath.During the procedure, while attempting to advance the 5f select through the right common carotid artery (cca) to perform an angiography via radial access, the physician fractured the 5f select at the distal length in the right subclavian artery.Therefore, the physician removed the 5f select and used a snare device to remove the fractured segment of the 5f select.The procedure was completed using a non-penumbra catheter and the same sheath.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
Evaluation of the returned 5f select confirmed that the catheter was fractured.This damage typically occurs if the device is manipulated against resistance during use.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed ovalization 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 devices are visually 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: 20157120
• Report Number: 3005168196-2024-00306
• Device Sequence Number: 4209523
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/01/2024
• 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: 09/29/2024
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: H11906
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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: 33 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005