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

Catalog Number	PND6F0701058
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
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 right carotid artery using a neuron 6f 070 delivery catheter (neuron 070).During the procedure, the physician was unable to advance a guidewire through the neuron 070 and found the distal third of the neuron 070 to be ovalized while advancing through the aorta and aortic arch within a non-penumbra sheath; therefore, the neuron 070 was removed.The procedure was completed using another catheter with the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron 070 was ovalized approximately 7.0, 13.0 thru 14.0, 60.5 and 108.0 cm from the hub.The distal tip of the neuron 070 was stretched approximately 103.5 thru 107.5 cm.The total length of the stretched device was approximately 113.0 cm from the hub.Conclusions: evaluation of the returned neuron 070 revealed that the catheter was ovalized.If the device is forcefully gripped or pinched during use, damage such as ovalization may occur.Some of these ovalizations may have been incidental to the reported issue and may have occurred while packaging the device for return.Further evaluation of the returned neuron 070 revealed that the catheter shaft was stretched.If the guidewire was unable to advance past the distal ovalization, forcefully advancing the guidewire may have caused the stretching observed on the returned device.The non-penumbra sheath identified in the complaint was not returned to penumbra 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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report.Section h.Box 4.Device manufacture date.

• 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: 8219190
• Report Number: 3005168196-2019-00023
• Device Sequence Number: 1656541
• Product Code: DQY
• UDI-Device Identifier: 00814548010045
• UDI-Public: 00814548010045
• 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,Followup
• Report Date (Section B): 12/07/2018
• 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: 11/09/2020
• Device Catalogue Number: PND6F0701058
• Device Lot Number: F80506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 02/27/2019; 01/14/2005
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 04/03/2019; 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005