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

Catalog Number	PND6F1056M
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	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the shipper box was dented on its side.The tape that holds the packaging mandrel to the packaging card appeared to have been ripped off.The distal tip of the neuron 053 was kinked from approximately 100.0-105.0 cm from the proximal hub.Conclusions: evaluation of the device revealed that the distal tip of the neuron was damaged.The tape that holds the packaging mandrel to the packaging card was ripped off.If the mandrel is removed from the packaging card while still inserted in the neuron 053 distal tip, damage such as this may occur.Penumbra 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.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff noticed that the distal end of a neuron 6f 053 delivery catheter (neuron 053) was kinked upon removal from the packaging.The damage to the neuron 053 was found prior to use and therefore, it was not used in the procedure.The procedure was completed using a new neuron 053.

• 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: 6509133
• Report Number: 3005168196-2017-00600
• Device Sequence Number: 13770303
• Product Code: DQY
• UDI-Device Identifier: 00814548010113
• UDI-Public: 00814548010113
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Report Date (Section B): 03/21/2017

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: 12/27/2019
• Device Catalogue Number: PND6F1056M
• Device Lot Number: F73326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1