MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Catalog Number	PNML6F088804
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/27/2019
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 hospital staff noticed that a neuron max 6f 088 long sheath (neuron max) was damaged upon opening of the packaging.The damage to the neuron max was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new neuron max.
Additional Manufacturer Narrative
Results: the neuron max was kinked approximately 32.0 and 39.5 cm from the hub.The device was ovalized from approximately 46.0 ¿ 48.0 and 76.0 cm from the hub.Conclusions: evaluation of the returned neuron max confirmed ovalizations on the mid-shaft and near the distal tip.If the device is forcefully gripped or otherwise mishandled at extreme angles during removal from its packaging, damage such as ovalizations may occur.Further evaluation revealed kinks.Based on the return condition, these kinks were likely incidental to the reported complaint.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.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8569222
• Report Number: 3005168196-2019-00836
• Device Sequence Number: 2192077
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019
• 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: 06/12/2021
• Device Catalogue Number: PNML6F088804
• Device Lot Number: F83989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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