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

Model Number	PND6F070956M
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 070 was ovalized approximately 95.0 cm from the hub.The neuron 070 was kinked approximately 20.5, 21.5, 47.0, and 49.0 cm from the hub.Conclusions: evaluation of the returned neuron 070 revealed that the device was ovalized and kinked.If the device is retracted out of its packaging tube at an extreme angle or mishandled during preparation, damage such as this may occur.Further evaluation of the neuron 070 revealed that the device was kinked in multiple locations.These kinks were likely incidental to the reported issue and may have occurred due to the packaging of the device 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 found that the tip of the neuron 6f 070 delivery catheter (neuron 070) was damaged when the physician wanted to flush the device on the back table.The damage to the neuron 070 was found prior to use.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: 7764133
• Report Number: 3005168196-2018-01527
• Device Sequence Number: 1230870
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2018
• 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: 01/23/2021
• Device Model Number: PND6F070956M
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F81585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 02/03/2020; 02/03/2020
• 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