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

Model Number	PND6F0701058M
Medical Device Problem Codes	Break (1069); Component Missing (2306); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2020
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
The patient was undergoing a medical procedure in the left middle cerebral artery (mca) using a neuron 6f 070 delivery catheter (neuron 070) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician attempted to insert the neuron 070 into the neuron max without the use of the peel-away sheath; however, the distal end of the neuron 070 became kinked and broke outside of the neuron max.Therefore, the neuron 070 was removed.It was reported that the peel-away sheath was missing from the packaging.The procedure was completed using a new neuron 070 and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron 070 was kinked approximately 103.5 ¿ 104.5 cm from the hub.The device was ovalized approximately 108.5 ¿ 111.0 cm from the hub.Conclusions: evaluation of the returned neuron 070 confirmed a kink on the distal shaft.If the device is forcefully advanced against resistance, damage such as this may occur.Further evaluation revealed an ovalization near the distal tip.If the peel-away sheath is not properly utilized prior to advancement of the neuron 070 into a parent device, damage such as an ovalization may occur.This damage likely contributed to the resistance during advancement.During functional testing, the neuron 070 was unable to be advanced through a demonstration neuron max due to the kink.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: 10486128
• Report Number: 3005168196-2020-01365
• Device Sequence Number: 19856806
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 08/11/2020
• 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: 02/01/2021
• Device Model Number: PND6F0701058M
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F81736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005