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

Model Number	PND6F0701058M
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a left internal carotid artery (ica)-posterior communicating artery (pcom) aneurysm using a neuron 6f 070 delivery catheter (neuron 070) and a non-penumbra short sheath.It was reported that patient anatomy was tortuous.During the procedure, the physician placed the short sheath and then advanced the neuron 070 into the sheath.While advancing the distal end of the neuron 070 approximately 60 centimeters into the patient, the physician experienced resistance and subsequently, the neuron 070 kinked.Therefore, the neuron 070 was removed.The procedure was completed using a new neuron 070 and the same short sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron 070 was kinked approximately 69.0 cm from the hub.The neuron max was ovalized approximately 77.0, 78.5, 79.5, 101.5 and 108.0 cm from the hub.Conclusions: evaluation of the returned neuron 070 confirmed that the catheter was kinked.If the neuron 070 is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned neuron 070 revealed ovalization along the catheter shaft.These ovalizations may have been a result of advancing the device through the tortuous anatomy and may have contributed to the reported resistance.During functional testing, resistance was encountered while advancing the returned neuron 070 through a demonstration neuron max due to the ovalization in the distal shaft, and the neuron 070 could not be advanced any further.No other devices associated with the complaint were returned for evaluation.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.H3 other text : placeholder.

• Brand Name: NEURON DELIVERY CATHETER 070
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9988660
• Report Number: 3005168196-2020-00584
• Device Sequence Number: 17292581
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• 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): 04/01/2020
• 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: 03/20/2022
• Device Model Number: PND6F0701058M
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F89144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005