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

Model Number	PNS5F120BER
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure for a four vessel angiogram using a neuron select catheter 5f (5f select), wire, non-penumbra wire, and short femoral sheath.During the procedure, upon setting up for the diagnostic angiogram, a 5f select was flushed, but a wire was unable to pass through the lumen of the 5f select.Therefore, the 5f select was removed.The procedure was completed using a new 5f select and the same wire and short femoral sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 5f select revealed ovalizations through the length of the device.If the device is manipulated against resistance at extreme angles during use, damage such as this may occur.During functional testing, a demonstration guidewire was advanced through the 5f select with resistance due to the ovalizations.The 5f select with a guidewire within its lumen were unable to be advanced through a demonstration benchmark due to resistance caused by the ovalizations.The ovalizations likely contributed to the resistance while advancing the guidewire wire during the procedure.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.

• Brand Name: NEURON SELECT CATHETER 5F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12261969
• Report Number: 3005168196-2021-01721
• Device Sequence Number: 3635405
• Product Code: DQY
• UDI-Device Identifier: 00814548010182
• UDI-Public: 00814548010182
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021
• 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: 01/15/2023
• Device Model Number: PNS5F120BER
• Device Catalogue Number: PNS5F120BER
• Device Lot Number: C25090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005