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

Catalog Number	PNS5F120BER
Medical Device Problem Codes	Break (1069); Material Separation (1562); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the following device code also applies to this complaint: (b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a medical procedure, the hospital staff noticed that the black tip of the neuron select 5f select catheter (5f select) came off upon removal from the packaging.The tip of the 5f select came off prior to use and therefore, the 5f select was not used for the procedure.The procedure was completed using a new 5f select.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was sent out for return; however, has not been received by the manufacturer.Therefore, 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 was not received by the manufacturer.

• Brand Name: NEURON SELECT 5F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6021902
• Report Number: 3005168196-2016-01454
• Device Sequence Number: 18940192
• Product Code: DQY
• UDI-Device Identifier: 00814548010182
• UDI-Public: 00814548010182
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/14/2016

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: 06/13/2019
• Device Catalogue Number: PNS5F120BER
• Device Lot Number: F70103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1