MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY

Catalog Number	PND6F0701058M
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
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
The patient was undergoing a medical procedure in the anterior communicating artery (acomm) using a neuron 6f 070 delivery catheter (neuron 070).During the procedure, the physician felt resistance and was unable to advance the neuron 070 completely through the non-penumbra sheath, despite using a guidewire.Therefore, the neuron 070 was removed.Upon removal, the physician noticed that the neuron 070 was kinked near the middle of the catheter.The procedure was completed using a new neuron 070 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron 070 was ovalized approximately 41.5 cm, 104.5 cm and 106.5-107.5 cm from the hub.The neuron 070 was kinked approximately 43.5 cm from the hub.A demonstration mandrel was attempted to be advanced into the neuron 070.Resistance was experience at the kinked location and the mandrel was unable to advance further.Conclusions: evaluation of the returned neuron 070 revealed a midshaft kink and distal ovalizations.If the device is forcefully gripped or pinched during introduction to a parent device, it may become ovalized.In addition, if the included peel away sheath is not properly used it may contribute to the catheter becoming ovalized on its distal end.The midshaft kink was likely a result of forcefully advancing the device against resistance.The ovalizations may have contributed to resistance experienced when attempting to advance the device.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 6F 070 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7716895
• Report Number: 3005168196-2018-01447
• Device Sequence Number: 13802479
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018
• 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: 12/07/2020
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F80918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005