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

Catalog Number	PND6F0701058M
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
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 using a neuron 6f 070 delivery catheter (neuron 070), a hospital staff found that the end of the neuron 070 was kinked upon removal from the packaging.The damage to the neuron 070 was found prior to use and; therefore, was not used in the procedure.The procedure was completed using a new neuron 070.
Additional Manufacturer Narrative
Results: the neuron 070 was kinked approximately 64.5 cm, 76.0 cm, and 98.5 cm from the hub.The device had a bend approximately 81.0 cm from the hub.The device was ovalized approximately 101.0 cm -106.0 cm, 107.0 cm and 110.0 cm from the hub.Conclusions: evaluation of the returned neuron 070 revealed a kinked and ovalized device.If the device is forcefully retracted from the packaging at extreme angles or otherwise mishandled during preparation, damage such as kinks and ovalizations may occur.Further evaluation revealed a bend along the length of the device.Based on the return condition, the bend is likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: NEURON DELIVERY CATHETER 070
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8048654
• Report Number: 3005168196-2018-02210
• Device Sequence Number: 1435923
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018
• 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: 12/12/2020
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F80993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 03/08/2019
• 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