MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 053 DELIVERY CATHETER; DQY

Catalog Number	PND6F1056
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2016
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.This report is associated with mfr report number: 3005168196-2016-00608.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a medical procedure using neuron 6f 053 delivery catheters (neuron 053).During the procedure, while introducing a neuron 053, the physician noticed that it was kinked.The neuron 053 was then removed and a new neuron 053 was opened to continue the procedure.However, while in use, it was observed that this second neuron 053 was kinked near the hub.Therefore, the physician removed the neuron 053 and successfully completed the procedure using a new neuron 053.There was no report of an adverse effect to the patient.Please note that exact date of event is unknown; however, the customer indicated that the event occurred in (b)(6) of 2016.

• Brand Name: NEURON 6F 053 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5630849
• Report Number: 3005168196-2016-00609
• Device Sequence Number: 18881882
• Product Code: DQY
• UDI-Device Identifier: 00814548010106
• UDI-Public: 00814548010106
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K070970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2016

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: Physician
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: PND6F1056
• Device Lot Number: F43708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2016
• Initial Report FDA Received Date: 05/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1