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

Catalog Number	PND6F11512M
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Difficult to Open or Remove Packaging Material (2922); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2016-00860.
Event or Problem Description
During preparation for a medical procedure, the physician had difficulty removing a neuron 6f 070 delivery catheter (neuron 070) and a neuron 6f 053 delivery catheter (neuron 053) from their support mandrels and support cards.In addition, the physician noticed that the tips of neuron 070 and neuron 053 were deformed.The damaged neuron 070 and neuron 053 were noticed prior to use and therefore, were not used for the procedure.The procedure was completed using a new neuron device.
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 hospital disposed of the device.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up #01 and is being corrected on this follow-up #02 mfr report: 1.Date received by manufacturer.This report is associated with mfr report number: 1.3005168196-2016-00860.

• 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: 5748512
• Report Number: 3005168196-2016-00861
• Device Sequence Number: 10763266
• Product Code: DQY
• UDI-Device Identifier: 00814548010137
• UDI-Public: 00814548010137
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• PMA/510(K) Number: K070970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2016
• 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: Physician
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: PND6F11512M
• Device Lot Number: F67035
• 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: 05/25/2016
• Supplement Date Received by Manufacturer: Not provided; 12/08/2016
• Initial Report FDA Received Date: 06/24/2016
• Supplement Report FDA Received Date: 12/08/2016; 05/09/2019
• 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