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

Catalog Number	PND6F0701058
Medical Device Problem Codes	Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2017
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 thrombectomy procedure using a neuron delivery catheter 070 (neuron 070).During the procedure, after successfully making passes, the physician experienced resistance while advancing a stent through the neuron 070 and the neuron 070 became stretched.Therefore, the neuron 070 was removed and the procedure was completed using a new neuron 070 and the same stent.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device is not available for return.

• 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: 6407004
• Report Number: 3005168196-2017-00369
• Device Sequence Number: 797859
• Product Code: DQY
• UDI-Device Identifier: 00814548010045
• UDI-Public: 00814548010045
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2017

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: Physician
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: PND6F0701058
• Device Lot Number: F64912
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1