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 Patient Involvement (2645)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 070 was ovalized 29.0-29.5, 33.5, 66.5-67.0, 102.5-103.0, 106.0-107.0, and 110.0-111.0 cm from the hub.The neuron 070 was kinked approximately 15.5 and 108.0 cm from the hub.Conclusions: evaluation of the returned neuron 070 confirmed a device with kinks and ovalizations.The kinks and ovalization may occur due to forceful manipulation at extreme angles during removal of the device from the packaging.Further evaluation revealed the packaging mandrel was unsecured from the packaging tape and packaging card.If this occurs and the device is retracted, the packaging mandrel may pin the device between the packaging mandrel and the packaging card and damage such as kinks and ovalizations may occur.Based on the return condition and the reported complaint, some of the bends and kinks are likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra catheters are visually 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.
Event or Problem Description
During preparation for a medical procedure, the hospital staff noticed the neuron 6f 070 delivery catheter (neuron 070) tip was kinked.The damaged neuron 070 was found prior to use and, therefore, the neuron 070 was not used in the procedure.The procedure was completed using a new neuron 070.

• Brand Name: NEURON DELIVERY CATHETER 070
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7986706
• Report Number: 3005168196-2018-02082
• Device Sequence Number: 13498231
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K082290
• 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
• Report Date (Section B): 09/21/2018
• 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: 09/11/2020
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F79469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/19/2018
• 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