MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX; DQY

Catalog Number	PNML6F0881004
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron max was ovalized approximately 56.0, 90.0, and 101.5 thru 102.5 cm from the hub.Resistance was encountered while advancing the returned 6f select through the returned neuron max and the 6f select could not be advanced any further.Conclusions: evaluation of the returned neuron max revealed that the device was ovalized.If the device is forcefully gripped or pinched during preparation, damage such as this may occur.The ovalization in the neuron max likely contributed to the 6f select¿s inability to advance through the sheath during preparation.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2018-02169.
Event or Problem Description
During preparation for a medical procedure, a neuron 6f select catheter (6f select) would not advance all the way through the distal tip of a neuron max 6f 088 long sheath (neuron max) on the back table; therefore, both neuron max and 6f select were not used in the procedure.The procedure was completed using a new neuron max and 6f select.There was no patient involved.

• Brand Name: NEURON MAX
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8035661
• Report Number: 3005168196-2018-02170
• Device Sequence Number: 19158142
• Product Code: DQY
• UDI-Device Identifier: 00814548012292
• UDI-Public: 00814548012292
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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
• Report Date (Section B): 10/03/2018
• 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: 09/12/2020
• Device Catalogue Number: PNML6F0881004
• Device Lot Number: F79494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• 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: 10/03/2018
• Initial Report FDA Received Date: 11/02/2018
• 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