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

Catalog Number PND6F0701058M

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2015

Event Type  malfunction  

Manufacturer Narrative

Result: the neuron 070 was kinked approximately 33.0 cm and 51.0 cm from the hub and in multiple locations from the distal tip to approximately 14.5 cm from the distal tip.Conclusion: the complaint has been evaluated.The initial complaint indicated that upon removal from packaging, the distal end of the neuron 070 was found to be flattened.Evaluation of the returned device revealed kinks in multiple locations along the distal shaft of the catheter, as well as kinks on the distal tip itself.The distal tip is protected by a packaging mandrel while packaged, which indicates that the damage likely occurred during removal of the device from the packaging tube, instead of during transit.If the device is removed from packaging with force at an angle, it is likely that this damage may occur.Further evaluation revealed kinks on the proximal shaft of the catheter.This type of damage likely occurred due to improper handling during packaging for return shipping.These devices 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 Description

The patient was undergoing a medical procedure using a neuron 6f 070 delivery catheter.Upon removal from the packaging, the neuron catheter was found ovalized and was not used.

• Brand Name: NEURON 6F 070 DELIVERY CATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4923400
• MDR Text Key: 22507788
• Report Number: 3005168196-2015-00693
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K082290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F35304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1