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

Model Number	BMK6F95BER120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
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 medical procedure in the right internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), a neuron select catheter 5f (5f select) and a non-penumbra short sheath.During the procedure, the physician advanced the 5f select over a guidewire through the short sheath and benchmark through the common iliac artery (cia) and descending aorta.The guidewire was then removed and the 5f select was flushed.The physician then advanced the benchmark over the 5f select for more support and once the 5f select advanced over the transition point, the distal end of the 5f select broke off.The physician then removed the broken 5f select using a snare device from the left common femoral artery.The procedure was completed using a new 5f select and a new benchmark.It should be noted that there was no alleged device deficiency or damage to the first benchmark.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 5f select confirmed a fracture at the distal shaft.Based on the reported event, a guidewire was not present inside the 5f select when it became fractured.This may have contributed to the 5f select becoming fractured when tracking the benchmark over it.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 13260443
• Report Number: 3005168196-2022-00014
• Device Sequence Number: 1463448
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022
• 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: 06/24/2024
• Device Model Number: BMK6F95BER120
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F107342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• 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: 12/17/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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: 69 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005