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); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron max had an unknown substance on the outside of the catheter shaft.The neuron max was ovalized approximately 66.5 and 81.5 cm from the hub.Conclusions: evaluation of the returned neuron max revealed that the sheath shaft had an unknown substance on it.The unknown substance could not be determined.Also, the hydrophilic coating was present on the catheter shaft.Further evaluation of the returned neuron max revealed that the shaft was ovalized.The ovalization was likely incidental to the reported issue and may have occurred while packaging the device for return to penumbra.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 physician noticed a "glue like substance" mid way up the shaft the neuron max 6f 088 long sheath (neuron max).The substance was found prior to use and, therefore, the neuron max was not used in the procedure.The procedure was completed using a new neuron max.

• 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: 7900296
• Report Number: 3005168196-2018-01865
• Device Sequence Number: 169862
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2018
• 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: 01/16/2021
• Device Catalogue Number: PNML6F088804
• Device Lot Number: F81464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/21/2018
• 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