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	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 053 was kinked approximately 100.0 cm from the hub.Conclusions: evaluation of the returned device confirmed that the neuron 053 was kinked.This type of damage typically occurs due to improper handling during removal from the packaging.If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur.A mandrel was attempted to be advanced through the neuron 053.While advancing the mandrel, resistance was encountered as the mandrel met the kink in the distal catheter shaft and the mandrel could not be advanced any further.Penumbra catheters are visually 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 medical procedure, the hospital staff found that the 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: 7289236
• Report Number: 3005168196-2018-00368
• Device Sequence Number: 13765523
• Product Code: DQY
• UDI-Device Identifier: 00814548010113
• UDI-Public: 00814548010113
• Combination Product (Y/N): Y
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018
• Report Date (Section F): 01/01/2005

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: 08/10/2020
• Device Catalogue Number: PND6F1056M
• Device Lot Number: F78642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005