MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY

Catalog Number	PND6F070956M
Medical Device Problem Codes	Fracture (1260); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 neuron 6f 070 delivery catheter (neuron 070) was fractured at the distal tip upon removal from the packaging.The damaged neuron 070 was found prior to use and therefore, was not used in the procedure.The procedure was completed using another neuron 070.
Additional Manufacturer Narrative
Please note the device is no longer available for return as mentioned in the initial mdr; therefore, the mdr was updated accordingly.The product was disposed of by the hospital and is no longer available for return.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 hospital discarded the device.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report: operator of device.Report source.

• Brand Name: NEURON 6F 070 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6849513
• Report Number: 3005168196-2017-01517
• Device Sequence Number: 10779448
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• PMA/510(K) Number: K082290
• 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,Followup,Followup
• Report Date (Section B): 08/11/2017
• 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: 12/30/2019
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F73454
• 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: 08/11/2017
• Supplement Date Received by Manufacturer: 04/10/2018; 01/14/2005
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 04/11/2018; 02/08/2019
• 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