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

Catalog Number	PNS5F130BER
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
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.
Event or Problem Description
During preparation for medical procedure, the hospital staff found that the neuron select 5f select catheter (5f select) was kinked upon removal from the packaging.The damage to the 5f select was found prior to use, and therefore it was not used in the procedure.The procedure was completed using a new 5f select.
Additional Manufacturer Narrative
Occupation.Health professional.

• 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: 7197719
• Report Number: 3005168196-2018-00132
• Device Sequence Number: 16518294
• Product Code: DQY
• UDI-Device Identifier: 00814548010212
• UDI-Public: 00814548010212
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): 12/18/2017
• 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: 09/21/2020
• Device Catalogue Number: PNS5F130BER
• Device Lot Number: F79683
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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