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

Catalog Number	PND6F0701058
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 6f 070 delivery catheter (neuron) 070 was kinked where the packaging was folded in half.The neuron 070 was kinked in multiple locations along the mid-shaft, and was ovalized in the distal shaft.The distal tip of the neuron 070 was bent.The distal tip surface of the catheter felt and appeared rough prior to the decontamination procedure.Closer evaluation revealed that the distal tip was covered in a foreign substance, and once the substance was rinsed off with water the distal tip felt and appeared smooth and lubricious.Conclusions: evaluation of the returned device revealed a foreign substance on the distal tip of the neuron 070.If proper care is not taken to keep the neuron 070 sterile after it is removed from its sterile pouch, it may become contaminated.Further evaluation revealed multiple kinks along the catheter shaft.This damage was likely incidental, and may have occurred due to improper handing during packaging for return transit.Penumbra catheters are 100% visually inspected during in process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a medical procedure, the hospital staff noticed that the tip of a neuron 6f 070 delivery catheter (neuron 070) was "too rough".The "rough" tip was found prior to use and therefore, the neuron 070 was not used for the procedure.The procedure was completed using a new neuron 070.

• 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: 5535483
• Report Number: 3005168196-2016-00402
• Device Sequence Number: 562055
• Product Code: DQY
• UDI-Device Identifier: 00814548010045
• UDI-Public: 00814548010045
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2016

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: 11/30/2018
• Device Catalogue Number: PND6F0701058
• Device Lot Number: F66687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2016
• Initial Report FDA Received Date: 03/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1