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

Catalog Number	PND6F0701058
Medical Device Problem Codes	Collapse (1099); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/09/2017
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
During preparation for a medical procedure, the hospital staff noticed that the distal end of the neuron 6f 070 delivery catheter (neuron 070) was collapsed upon removal from the packaging.Furthermore, a guidewire could not be advanced through the lumen of the neuron 070.The damaged neuron 070 was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new neuron 070.
Additional Manufacturer Narrative
The neuron 6f 070 delivery catheter (neuron 070) was ovalized and twisted approximately 103.0 cm from the hub and ovalized approximately 109.0 cm from the hub.During functional analysis, a 0.035¿ mandrel was inserted into the neuron 070, but could not be advanced pass the distal ovalization.Evaluation of the returned device revealed an ovalization near the distal tip.This damage may have occurred due to forceful gripping or pinching of the neuron 070 during removal from the packaging.The observed ovalization likely prevented the guidewire from advancing.Penumbra coils and 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: 6730745
• Report Number: 3005168196-2017-01199
• Device Sequence Number: 13673442
• Product Code: DQY
• UDI-Device Identifier: 00814548010045
• UDI-Public: 00814548010045
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

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: Health Professional
• Device Expiration Date: 02/08/2020
• Device Catalogue Number: PND6F0701058
• Device Lot Number: F74331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1