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

Catalog Number	PNS5F130SIM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was undergoing a medical procedure using a neuron select catheter 5f (5f select), a balloon guide catheter and a guidewire.During the procedure, the physician advanced 5f select through the right femoral artery during the first pass and noticed under fluoroscopy that the distal length of the 5f select had fractured and was lodged in the iliac artery.Therefore, the physician used a snare to successfully remove the fractured segment of the 5f select.There was no additional adverse effect to the patient.The procedure was completed using a neuron select catheter 6f (6f select) and the balloon catheter.
Additional Manufacturer Narrative
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 root cause of the resistance could not be determined.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.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: 18909425
• Report Number: 3005168196-2024-00083
• Device Sequence Number: 20554630
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 814548010236
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/30/2024
• 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: 08/08/2024
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: H11671
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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
• Patient Age: 53 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005