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

Catalog Number	PND6F070956
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 6f 070 delivery catheter (neuron 070) was kinked in multiple locations along the catheter shaft approximately 39.0, 58.0, 64.5, 90.0, and 96.0 cm from the hub.Conclusions: evaluation of the returned device confirmed that the neuron 070 was kinked in multiple locations along the catheter shaft.This type of damage typically occurs due to improper handling during storage or preparation.If the device is manipulated with force at extreme angles, damage such as this may occur.Neuron 070 devices are 100% visually inspected for damage 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 neuron 6f 070 delivery catheter (neuron 070) was kinked.The kinked neuron 070 was found prior to use and 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: 5563490
• Report Number: 3005168196-2016-00461
• Device Sequence Number: 384261
• Product Code: DQY
• UDI-Device Identifier: 00814548010069
• UDI-Public: 00814548010069
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 03/10/2016

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: 04/30/2018
• Device Catalogue Number: PND6F070956
• Device Lot Number: F63771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2016
• Initial Report FDA Received Date: 04/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1