MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 053 DELIVERY CATHETER; DQY

Catalog Number	PND6F1156
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	03/05/2016
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 physician noticed that the distal part of a neuron 6f 053 delivery catheter (neuron 053) was damaged and kinked upon removal from the packaging.The damaged neuron 053 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new neuron 053.
Additional Manufacturer Narrative
Result: the distal tip of the neuron delivery catheter 053 (neuron 053) was ovalized approximately 0.5 and 1.0 cm from the distal tip.Conclusion: evaluation of the returned device confirmed that the distal tip of the neuron 053 was damaged.This type of damage likely occurred due to improper handling during removal from the packaging or preparation.If the device is forcefully gripped or pinched during removal from the package or preparation, damage such as this may occur.Neuron 053s 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.

• Brand Name: NEURON 6F 053 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5645626
• Report Number: 3005168196-2016-00636
• Device Sequence Number: 307035
• Product Code: DQY
• UDI-Device Identifier: 00814548010144
• UDI-Public: 00814548010144
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K070970
• 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): 04/11/2016

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: Physician
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: PND6F1156
• Device Lot Number: F65594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2016
• Supplement Report FDA Received Date: 06/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1