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

Catalog Number	PND6F0701058M
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
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 using a neuron 6f 070 delivery catheter (neuron 070).During the procedure, the physician found that the tip of the neuron 070 had become twisted while advancing through a neuron max 6f 088 long sheath (neuron max).Therefore, the neuron 070 was removed.The procedure was completed using a neuron 6f 053 delivery catheter (neuron 053) with the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron 070 was ovalized from approximately 57.0 ¿ 58.5 cm, 78.5 cm and from 99.0 ¿ 108.5 cm from the hub.During functional testing, resistance was encountered at the distal ovalized location while advancing the neuron 070 through a demonstration neuron max and the device could not advance any further.Conclusions: evaluation of the returned neuron 070 confirmed an ovalization on the distal end of the device.If the neuron 070 is forcefully gripped or mishandled while advancing the device through a neuron max, the device may become ovalized.Further evaluation revealed additional ovalizations along the device which, based on the returned condition and reported complaint, were likely incidental and may have occurred during packaging for return to penumbra.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: 8137695
• Report Number: 3005168196-2018-02371
• Device Sequence Number: 13925129
• 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): 11/06/2018
• 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: 11/02/2020
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F80342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005