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

Catalog Number	PNS5F130BER
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device is being held by the hospital risk management department.
Event or Problem Description
The patient was undergoing a thrombectomy procedure treating a stroke using a neuron 5f select catheter (5f select).During the procedure, while advancing the 5f select through a non-penumbra guide catheter, the tip of the 5f select fractured and fell off in the patient's aorta.Therefore, the physician required a snare device to successfully retrieve the broken tip from the patient prior to treating the stroke.The physician did not mention resistance while using the 5f select and the patient did not have tortuous anatomy.Thereafter, the physician used another manufacturer's select catheter to successfully treat the stroke.There was a minimum delay of 45 minutes in treating the stroke due to the damaged 5f select catheter.It is unknown if there was an adverse effect to the patient related to the delay in the treatment.
Additional Manufacturer Narrative
Results: the neuron 5f select catheter (5f select) was fractured at the proximal and distal shaft junction.There was no gross yielding proximal or distal to the fracture.The distal shaft was kinked near the fracture.The distal segment of the select was creased.Conclusions: evaluation of the returned select revealed it was fractured at the proximal and distal shaft junction.If the select is forcefully handled at extreme angles during insertion or use in the patient anatomy, the catheter may become weakened, and damage such as this may occur.Evaluation of the select distal segment revealed a slight crease.The observed crease was likely caused by the select being handled at extreme angles.Further evaluation revealed that the distal shaft was kinked near the fracture.This damage was likely incidental, and may have been caused by the physician snaring the segment out of the aorta.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 5F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5951171
• Report Number: 3005168196-2016-01324
• Device Sequence Number: 16324913
• Product Code: DQY
• UDI-Device Identifier: 00814548010212
• UDI-Public: 00814548010212
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K070970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2016

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: Physician
• Device Expiration Date: 06/07/2019
• Device Catalogue Number: PNS5F130BER
• Device Lot Number: F70002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 11/14/2016
• 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
• Patient Age: 70 YR