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

Model Number	PNS5F130BER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
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 thrombectomy procedure in the venous sinus using a neuron select catheter 5f (5f select) and a guidewire.During the procedure, the physician advanced a 5f select over a guidewire through the tortuous internal carotid.Next, the guidewire was removed temporarily and subsequently, it was noticed that the distal tip of the 5f select broke off.It was also reported that the distal tip of the 5f select was fractured and disconnected at the junction from black to purple.Afterwards, the physician used a snare device to remove the broken distal tip of the 5f select without issue.The procedure was completed using a new 5f select.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 5f select confirmed a distal fracture.Fractures typically occur due to manipulation against resistance.Based on the reported event, the catheter was being manipulated within patient anatomy without a guidewire.This may have contributed to the damage experienced during the procedure.Further evaluation revealed ovalization on the distal fractured segment.This damage likely occurred during snaring of the device upon removal.Penumbra catheters 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
• MDR Report Key: 11891332
• Report Number: 3005168196-2021-01166
• Device Sequence Number: 3686126
• Product Code: DQY
• UDI-Device Identifier: 00814548010212
• UDI-Public: 00814548010212
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: PNS5F130BER
• Device Catalogue Number: PNS5F130BER
• Device Lot Number: F103089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005