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

Catalog Number	PNS5F130SIM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
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 cerebral arteriogram of the right common carotid artery (cca) to check the right carotid artery of a previously treated unruptured aneurysm using a neuron select catheter 5f (5f select), a guidewire, and a non-penumbra short introducer sheath.During the procedure, the physician advanced the 5f select over the guidewire through the short sheath and into the patient via radial approach.The physician then administered two contrast injections.Afterwards, between the second injection of contrast and the 3d sequence, the quality of the image had decreased, and the physician noticed that the guidewire would not pass through the distal end of the 5f select.The physician also noticed that the distal end of the 5f select was broken but remained connected.Therefore, the physician decided to remove the 5f select.While retracting the 5f select, the distal end of the 5f select broke off in the radial artery.The physician then used a non-penumbra long introducer sheath and a snare device to remove the broken distal end of the 5f select.The procedure was completed with a bolus injection.It was reported that a final control of the radial artery was achieved without an issue and that the aneurysm remained unruptured.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 5f select confirmed a fracture on the distal shaft.This damage typically occurs due to retraction against resistance.The root cause of the reported complaint could not be determined.The fractured distal segment was not returned for evaluation.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.H3 other text : placeholder.

• 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: 16077674
• Report Number: 3005168196-2022-00599
• Device Sequence Number: 6262651
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 814548010236
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/02/2023
• 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: 06/23/2025
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: H00000581
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005